This prospective study (n=86) evaluated the effects of ibogaine & 5-MeO-DMT treatment on risky alcohol use & PTSD symptoms among US Special Operations Forces Veterans. It found a significant reduction in alcohol use from pre-treatment to 1-month, 3-months, and 6-months post-treatment, and large differences between responders and non-responders in PTSD symptom and cognitive functioning change, suggesting that psychedelic-assisted therapy may hold promise for individuals with complex trauma and alcohol misuse.
This study evaluated prospective associations of ibogaine and 5-MeO-DMT treatment for risky alcohol use and post-traumatic stress disorder (PTSD) symptoms among United States (US) Special Operations Forces Veterans (SOFV). Data were collected during standard clinical operations at pre-treatment and 1-month (1 m), 3-months (3 m), and 6-months (6 m) post-treatment in an ibogaine and 5-MeO-DMT treatment program in Mexico. Of the 86 SOFV that completed treatment, 45 met criteria for risky alcohol use at pre-treatment (mean age = 44; male = 100%; White = 91%). There was a significant reduction in alcohol use from pre-treatment (M = 7.2, SD = 2.3) to 1 m (M = 3.6; SD = 3.5) post-treatment, which remained reduced through 6 m (M = 4.0; SD = 2.9; p < .001, partial eta squared = .617). At 1 m, 24% were abstinent, 33% were non-risky drinking, and 42% were risky drinkers. At 6 m, 16% were abstinent, 31% were non-risky drinking, and 53% were risky drinkers. There were no differences between responders (abstinent/non-risky drinkers) and non-responders (risky drinkers) in demographics/clinical characteristics. However, there were significant and very large differences between responders and non-responders in PTSD symptom (p < .01, d = −3.26) and cognitive functioning change (p < .01, d = −0.99). Given these findings, future clinical trials should determine whether psychedelic-assisted therapy holds promise for individuals with complex trauma and alcohol misuse who have not been successfully treated with traditional interventions.
Papers cited by this study that are also in Blossom
Bogenschutz, M. P., Forcehimes, A. A., Pommy, J. A. et al. · Journal of Psychopharmacology (2015)
Special Operations Forces (SOF) personnel are elite service members selected for high resilience and specialised training, yet they face repeated deployments, isolation, intense combat exposure and a raised risk of posttraumatic stress disorder (PTSD) and traumatic brain injury (TBI). Alcohol is the most commonly misused substance among military personnel and is frequently used to cope with combat-related stress, TBI sequelae and PTSD; these comorbidities are associated with poorer outcomes, higher relapse rates and elevated suicide risk. Available psychotherapies and pharmacotherapies for PTSD and alcohol misuse have limited efficacy for many Veterans, and there is a pressing need for transdiagnostic, effective interventions tailored to this complex population. This study sought to address a gap in prospective data on psychedelic-assisted interventions for Veterans with co-occurring alcohol misuse and trauma-related symptoms. Using a subgroup from a prospective clinical programme evaluation of combined ibogaine and 5-MeO-DMT treatment, the investigators aimed first to characterise alcohol use, PTSD symptoms and cognitive functioning from pre-treatment through six months post-treatment, and second to explore pre-treatment and treatment-related predictors of alcohol-use response versus non-response.
Data arose from routine clinical operations at a legal psychedelic treatment programme in Mexico between 2019 and 2021. Armstrong and colleagues report that referral was by word of mouth; referred Veterans completed medical and psychological screening to determine safety and contraindications. The residential programme lasted three days. On day one participants underwent urine drug and alcohol screening and preparatory work setting intentions. Those without contraindications received oral ibogaine hydrochloride at a reported dose of 10 mg/kg (99% purity) in a group setting (administered with up to five other participants), with cardiovascular and medical monitoring. The second day emphasised journalling and integration supports, including individual and group psychological sessions. On the final day, a preparatory session preceded 5-MeO-DMT administration delivered via at least three inhaled doses (reported as 5 mg, 15 mg and 30 mg) with additional 30 mg or 45 mg doses if desired effects were not achieved; post-dose processing and integration occurred the same day. Study data collection used online surveys (SurveyGizmo/Alchemer) at pre-treatment and at 1-, 3- and 6-months post-treatment. A staff member unaffiliated with the treatment site managed data collection; no incentives were provided. Of 99 Veterans treated during the period, the extracted text reports 86 completed the pre-treatment survey, 71 completed 1-month follow-up, 62 completed 3-month follow-up and 52 completed the 3-month follow-up (the extraction repeats “3-month” for the 52 count; the extracted text does not clearly report the number completing the 6-month survey). Forty-four participants completed all four surveys. An intention-to-treat approach was used with the most recently completed time point carried forward for missing data (last observation carried forward), yielding an analytic sample of 86 Veterans, of whom 45 screened positive for alcohol misuse and were included in the present subgroup analyses. Outcome measures were routine clinical instruments: the AUDIT-C for alcohol use (AUDIT-C ≥ 4 indicating possible misuse), the PCL-5 for DSM-5 PTSD symptoms, and the 22-item Neurobehavioral Symptom Inventory (NSI-22) for post-concussive cognitive symptoms. Internal consistency (Cronbach’s alpha) for these scales in this sample ranged roughly .73–.88 for AUDIT-C, .94–.96 for PCL-5, and .92–.93 for NSI-22. Analyses used IBM SPSS v28. The investigators ran three repeated-measures ANOVAs (one each for alcohol use, PTSD symptoms and cognitive functioning) across time points through six months. They computed change scores (pre-treatment minus 1-month follow-up) and compared responder and non-responder groups using t-tests on pre-treatment and 1-month scores. Responders were defined as abstinent or engaging in non-risky drinking versus non-responders classified as risky drinkers. Effect sizes were reported as partial eta squared for ANOVAs and Cohen’s d for t-tests, with significance at p < .05.
Among the 45 Veterans who screened positive for alcohol misuse at baseline, baseline risk severity distributed as 29% moderate-risk (AUDIT-C = 4–5), 29% high-risk (6–7) and 42% severe-risk (8–12). The subgroup was predominantly male (100%), largely White (reported as 87.2% in the main text; 91% appears in the abstract), non-Hispanic (89.5%), and middle-aged (mean age 42.9, SD = 7.9). Repeated-measures analyses indicated significant, very large reductions from pre-treatment to 1-month post-treatment in all three primary outcomes that were maintained through six months. Alcohol use declined significantly (p < .001, partial eta squared = .62), PTSD symptoms declined significantly (p < .001, partial eta squared = .59), and cognitive symptoms improved significantly (p < .001, partial eta squared = .52). In categorical terms, of those who reported risky drinking at baseline, 24% were abstinent, 33% were engaging in non-risky drinking and 42% remained risky drinkers at 1-month follow-up. At 3 months, proportions were 22% abstinent, 22% non-risky drinking and 56% risky drinking; at 6 months the distribution was 16% abstinent, 31% non-risky drinking and 53% risky drinking. Comparing responders (abstinent/non-risky; N = 26) to non-responders (risky drinkers; N = 19), there were no significant differences in baseline demographics or baseline clinical characteristics. However, responders showed substantially larger improvements from pre-treatment to 1-month in PTSD symptoms (p < .01, Cohen’s d = -3.26) and in cognitive functioning (p < .01, d = -0.99). The extracted text does not provide detailed adverse-event reporting or clinician-rated outcomes; all outcomes reported are self-reported measures collected via survey.
The investigators interpret these prospective clinical programme data as indicating that combined ibogaine and 5-MeO-DMT treatment was associated with rapid, substantial and sustained reductions in problematic alcohol use among this subgroup of Special Operations Forces Veterans, with parallel large reductions in PTSD symptoms and improvements in cognitive functioning. Treatment effects appeared within one month and were evident through six months in the measures reported. Responders to alcohol outcomes generally experienced larger reductions in trauma-related symptoms and greater cognitive improvement than non-responders. These findings are presented as consistent with prior research showing promise for psychedelics in treating PTSD and substance use disorders; the authors note that reductions in alcohol misuse in this sample were related to concurrent reductions in trauma symptoms and cognitive complaints. Nevertheless, several limitations are emphasised: the naturalistic programme evaluation lacked control conditions, randomisation and blinding, preventing causal inference and precluding separation of the effects of each compound or of combined dosing. Self-selection into treatment and survey participation may introduce bias, and reliance on self-report measures raises the possibility of reporting bias. The sample was largely middle-aged, White and male, which limits generalisability to broader Veteran and civilian populations. The authors call for well-designed randomised controlled trials comparing ibogaine and 5-MeO-DMT to placebo or control conditions, longer-term follow-up, inclusion of validated clinician-administered assessments and collateral informant reports, and measurement of ongoing stressors and traumatic exposures that may influence relapse to substance use.
Special Operations Forces (SOF) is composed of elite personnel chosen because of outstanding physical and psychological resilience who also have advanced training in difficult combat situations. However, SOF personnel are likely to experience many deployments, longer time away from home, more isolation, and potential intense combat situations, which can be traumatic and related to an increased risk of posttraumatic stress disorder (PTSD) and traumatic brain injury (TBI;. To cope with the high pressure of combat, physical injuries, and stress-and trauma-exposure-related psychological disorders, more than 1.5 million Veterans use alcohol which is the most misused substance among military personnel (National Survey on Drug. Alcohol is also commonly used to cope with the effects of TBI, a signature injury of conflicts in Iraq and Afghanistan among SOF Veterans (SOFV). Veterans with TBI are more likely to have comorbid psychological and neuropsychiatric issues, including PTSD, alcohol, or drug misuse, and cognitive impairment. For example, SOFV with combat acquired TBI were two times more likely to have alcohol-or drug-related diagnoses compared to other Veteran populations; and Veterans with a history of moderate-to-severe TBI were more likely to relapse to heavy drinking compared to those without TBI. SOFV have a strong sense of duty and significant mental health-related stigma, which likely influences their reluctance to seek mental health treatment. Currently, mental health crises and the incidence of suicides among SOFV are increasing at an alarming rate in the context of limited effective treatments for this unique population. More than 20% of highrisk behavior deaths among Veterans were attributed to substance misuse, and about 30% of completed suicides involved drug or alcohol use (National Survey on Drug Use and Health, 2013). Novel treatments are urgently needed to decrease alcohol misuse, stress-and traumarelated symptoms, and suicides in this population. Treatment paradigms must be developed with these complex factors in consideration to increase the health and wellbeing of this population. Available treatments for traumatic stress and alcohol misuse demonstrate limited efficacy in addressing the complex spectrum of psychiatric symptoms. Approved psychotherapies for addressing troubling memories (e.g., Cognitive Processing Therapy, Prolonged Exposure, Eye Movement Desensitization, and Reprocessing) and commonly used psychotherapies for addressing alcohol misuse (e.g., cognitive-behavioral therapy, motivational interviewing, mindfulness-based interventions) do not work for all Veterans due to their complex and co-occurring psychiatric symptoms, low response rates for engaged Veterans, and relatively high dropout rates from treatment programs. Further, pharmacotherapies, such as selective serotonin reuptake inhibitors, selective norepinephrine reuptake inhibitors, tricyclic antidepressants, mood stabilizers, antipsychotics, and psychostimulants, are commonly used to treat persistent physiological arousal, mood symptoms, or mitigate cognitive deficits. However, they demonstrate limited efficacy for people with PTSD, often have undesired side effects and long-term use needs,and the two Food and Drug Administration (FDA) approved medications for PTSD (i.e., sertraline, paroxetine) are slow acting and require weeks to take effect. This latency period increases the opportunity for risky behaviors such as self-medication and suicidal ideation/attempt. Pharmacotherapies, such as naltrexone, acamprosate, and disulfiram, which are commonly prescribed to help reduce alcohol withdrawal symptoms, exhibit limited efficacy for people with physical (e.g., liver disease) or mental issues and are associated hepatotoxicity, psychosis, and negative body reactions (e.g., headache, fatigue, nausea;. Given the comorbid psychological and neuropsychiatric issues among this population, transdiagnostic treatments that can simultaneously address PTSD and commonly overlapping comorbidities, such as alcohol misuse, are urgently needed. Recently, there has been increasing interest in the use of psychedelics as adjuncts to mental health treatment, such as depression, anxiety, substance use disorders (e.g.,, and the psychedelic 3,4-methylenedioxy-N-methamphetamine (MDMA) was granted Breakthrough Therapy designation by the FDA in 2017 for the treatment of PTSD. Recent phase 3 results of one clinical trial found that MDMA-assisted therapy was highly efficacious in individuals with severe PTSD, and treatment was safe and welltolerated, even in those with comorbidities. Furthermore, two recent clinical trials found longterm and robust improvements in alcohol use among participants who were administered psilocybinand MDMA. A retrospective study indicated significant and very large self-reported reductions in cognitive impairment and symptoms of PTSD from before to after combined ibogaine-and 5-MeO-DMT-assisted psychedelic therapy among SOFV. To address limitations associated with retrospective surveys, a prospective study that followed Veterans for sixmonth post-treatment was recently completed with a clinical program working with SOFV seeking ibogaineand 5-MeO-DMT-assisted therapy in Mexico. Study evidence showed that there were significant and large improvements in self-reported PTSD symptoms, postconcussive symptoms, and cognitive functioning from pre-treatment to one-month follow-up which were maintained at six-months. Although these preliminary data are encouraging, more research is needed to better understand prospective associations of psychedelic therapy among Veterans who misuse alcohol and experience co-occurring trauma-related symptoms. The goal of the present study was to address this gap in the literature by conducting secondary analysis using a subgroup from the prospective study described above. The first aim is to provide an overall characterization of alcohol use, PTSD symptoms, and cognitive functioning before and after treatment, through sixmonth follow-up. The second aim is to explore pre-treatment and other treatment characteristics that predict response and non-response on alcohol use outcomes.
Data were collected during standard clinical operations at a legal clinical psychedelic program in Mexico between 2019 and 2021. Comprehensive details of the clinical program can be found in a previously published study. Treatment involved psychedelic-assisted therapy with ibogaine and 5-MeO-DMT and referral to the program occurred by word of mouth. After being referred, Veterans underwent comprehensive physical and psychological screenings with the program's clinicians to determine participant safety and contraindications. The clinical residential program lasted three days. Participants underwent screenings (i.e., urine drug screening, alcohol) on the first day to ensure no contraindicated substances were detected. Further, they prepared for their psychedelic-assisted therapy by learning about ibogaine's effects and identified their treatment intentions. Participants whose screenings were clear of any contraindications were administered an oral dose of (10 mg/kg) of ibogaine hydrochloride (99% purity) with up to 5 others in a group setting. Each participant was monitored for cardiovascular and other medical issues while receiving fluids. The next day Veterans were encouraged to journal to process and integrate their experiences. Individual sessions with psychologists and group sessions were also offered to further support integration. On the final day, prior to receiving 5-MeO-DMT, the participants participated in a second preparatory session. At least three inhaled doses (5 mg, 15 mg, and 30 mg) were administered to each participant and additional doses (30 mg, 45 mg) were administered if no desired effects were experienced. The same day, after the effects subsided, Veterans processed and integrated their experiences.
During initial contact with the treatment program, Veterans were offered the opportunity to participate in this study. After consent and enrolling in the study, participants completed a pre-treatment survey before attending their retreat and then completed follow-up surveys at 1-, 3-, and 6-months after treatment. SurveyGizmo/ Alchemer, a secure online survey tool, was used to collect data from Veterans. A staff member not affiliated with the treatment site managed the data collection and no incentives were offered to those who completed surveys.
Measures administered were part of routine clinical practice at the treatment site (approved by the Institutional Review Board at Ohio State University) to evaluate the efficacy of combined ibogaine-and 5-MeO-DMT-assisted therapy for SOFV. Of the 99 Veterans who participated in treatment during the study period, 86 completed the pretreatment survey, 71 completed the 1-month follow-up, 62 completed the 3-month follow-up, and 52 completed the 3-month follow-up. 44 participants completed all four surveys. An intention-to-treat model was used to address the missing data, generating a conservative estimate of the treatment effect. Data from the most recently completed time point were carried over if they completed the pre-treatment survey. Thus, the sample was comprised of 86 participants, 45 of which screened positive for alcohol misuse and were included in the current analysis.
Veterans were asked items assessing their basic demographics including age, sex, education, military service, ethnicity, marital status, employment status, and state of residence.
Section A of the National Survey of Veterans (Westat, 2010) was modified to assess military history using 11items which included military status, military branch, and number of deployments.
Veterans completed the Alcohol Use Disorders Identification Test-Concise The AUDIT-C which comprises the first three items of the AUDITand is a validated measure of alcohol use. AUDIT-C scores of ≥ 4 indicated possible misuse (AUDIT-C;. Veterans reported their alcohol consumption before treatment and at each time point after their treatment. The mean of the total AUDIT-C after treatment was subtracted from the total AUDIT-C before treatment to calculate a change score. Cronbach's alphas for the current study ranged from .73 to .88 for each time point.
Veterans completed the Posttraumatic Stress Disorder Checklist (PCL-5) which assesses each of the DSM 5's 21 symptoms of PTSD. Veterans were asked to rate how bothered they were (0 = "Not at all" to 4 = "Extremely") by each of the symptoms in the 30 days before their treatment and at each time point after treatment. The mean of the total PCL-5 after treatment was subtracted from the total PCL-5 from before treatment to calculate a change score. Cronbach's alphas for the current study ranged from .94 to .96 for each time point. Cognitive symptoms. Veterans completed the Neurobehavioral Symptom Inventory (NSI-22;, a 22-item measure of symptoms commonly associated with post-concussive syndrome and mild traumatic brain injury. Veterans were asked to rate how bothered they were by each symptom on a 5-point scale (0 = "None," 4 = "Very severe"). The mean of the total NSI-22 after treatment was subtracted from the total NSI-22 from before treatment to calculate a change score. Cronbach's alphas for the current study ranged from .92 to .93 for each time point.
Analyses were conducted using IBM SPSS (Version 28). We initially calculated summary statistics of all demographics, background, and treatment history characteristics. To examine aim 1, we ran three separate repeatedmeasures ANOVAs to provide an overall characterization of alcohol use, PTSD symptoms, and cognitive functioning comparing symptoms from before to after treatment and through six-months follow up. We then calculated change scores for alcohol use, PTSD symptoms, and cognitive functioning by subtracting 1-month follow-up ratings from pre-treatment ratings. To examine aim 2, we ran a series of t-tests to compare the means of responder and non-responder groups at pretreatment and 1-month follow-up PTSD symptoms, cognitive functioning, and all demographic characteristics to evaluate pre-treatment and other treatment characteristics that predict response and non-response on alcohol use outcomes. Because there were no differences in primary outcome measures beyond 1-month followup, we compared pre-treatment to 1-month follow-up scores. Effect sizes for ANOVAs were calculated using the partial eta squared statistic and t-tests were calculated using the Cohen's d statistic and a p-value of .05 was used to determine statistical significance.
Of those that screened positive for possible alcohol misuse at pre-treatment (N = 45), 29% screened positive for moderate-risk drinking (AUDIT-C = 4-5), 29% screened positive for high-risk drinking (AUDIT-C = 6-7), and 42% screened positive for severe-risk drinking (AUDIT-C = 8-12). Respondents were largely Caucasian/White (87.2%), non-Hispanic (89.5%), middle-aged (M = 42.88, SD = 7.88), and male (100%; Table).
There was a significant and very large reduction in alcohol use from pre-treatment to 1-month posttreatment, which remained reduced through 6 months (p < .001, η 2 = .62). There was also a significant and very large reduction in PTSD symptoms from pre-treatment to 1-month post-treatment, which remained reduced through 6 months (p < .001, η 2 = .59). Lastly, there was a significant and very large improvement in cognitive functioning from pre-treatment to 1-month posttreatment (p < .001, η 2 = .52), which remained reduced through 6 months (Table). While, overall, there were significant and very large improvements in risky alcohol use, some Veterans continued to engage in risky drinking. Of the participants who reported risky drinking at pre-treatment, 24% were abstinent, 33% were engaging in non-risky drinking, and 42% were risky drinkers (18% = Moderate risk; 7% = High risk; 18% = Severe risk) at 1-month followup. At 3-months, 22% were abstinent, 22% were engaging in non-risky drinking, and 56% were risky drinkers (48% = Moderate risk; 20% = High risk; 32% = Severe risk). At 6-months, 16% were abstinent, 31% were engaging in non-risky drinking, and 53% were risky drinkers (24% = Moderate risk; 16% = High risk; 13% = Severe risk). There were no differences between responders (abstinent/non-risky drinkers; N = 26) and nonresponders (risky drinkers; N = 19) in pre-treatment demographics or pre-treatment clinical characteristics. However, there were significant and very large differences between responders and non-responders in changes in PTSD symptoms (p < .01, d = -3.26), and changes in cognitive functioning (p < .01, d = -0.99; Table), from before to 1-month after treatment.
This prospective clinical chart review study of combined ibogaine and 5-MeO-DMT treatment among SOFV suggests that this treatment is an effective and robust treatment to reduce problematic alcohol use. Not only were these outcomes established relatively quickly, effects maintained through 6 months post-treatment. There were no demographic differences between treatment responders and non-responders; however, responders had significantly larger reductions in trauma symptoms and improvements in cognitive functioning. These results are consistent with previous research investigating the impact of psychedelics on alcohol misuse. However, reductions were also related to reductions in trauma symptoms and improvements in cognitive functioning. In terms of trauma, psychedelics, especially MDMA, have been shown to improve PTSD symptoms. Psychedelics have also shown promise in improving cognitive functioning. This research extends the literature by using data from a prospective clinical program evaluation to follow this high-risk population of SOFV who received psychedelicassisted therapy. SOFV are particularly high-risk due to their strong sense of duty and significant mental health-related stigma, and among those with PTSD, dropout rates are often high when treatment is sought. Therefore, the data from this study are particularly beneficial as the treatment is brief and associated with improved symptomology and sustained clinical benefits which is in stark contrast to current therapeutics often used to treat common mental health concerns observed in SOFV. Some limitations to consider are the program Veterans attended occurred in a naturalistic setting which lacked any controls (e.g., control group, randomization, and blinding) limiting our ability to determine cause and effect relationships. Due to these limitations, we are unable to determine the clinical benefits resulting from each substance or evaluate the benefits of combined psychedelic drug dosing. Furthermore, participation in treatment was determined by self-selection. There may be something meaningful about those who chose to participate in this novel treatment and those who either did not participate or did not participate in survey completion. It is also notable that there were no objective reports, thus increasing risk of self-report bias. Finally, the population evaluated in this study is largely middle-aged, white, and male, which does not reflect the larger Veteran population or the general population of the United States and limits the generalizability of our findings. Future research should continue to develop and implement well-designed randomized controlled trials (RCTs) that allow for the comparison of ibogaine and 5-MeO-DMT to placebo/control groups. Well-crafted RCTs will allow for longer-term follow-up and assessment of the long-term effects of treatment. Further, researchers should also include validated clinicianadministered assessments and survey clinicians and other reporters, as their objective observations of treatment effectiveness is highly valuable. Lastly, because ongoing stress and continued traumatic experiences are associated with the return to substance use, including measures assessing these variables would be useful.
No potential conflict of interest was reported by the author(s).
Veterans Exploring Treatment Solutions AKD is supported by private philanthropic funding from Tim Ferriss, Matt Mullenweg, Craig Nerenberg, Blake Mycoskie, and the Steven and Alexandra Cohen Foundation. AKD, SBA, NS, and YX are also supported by the Center for Psychedelic Drug Research and Education, funded by anonymous private donors.
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