Clinical TrialTobacco/Nicotine Use Disorder (TUD)KetaminePlaceboCompleted

The Effects of Sedatives on Tobacco Use Disorder Version 2 (SED-TUD2)

Double-blind, randomised, placebo-controlled, crossover mechanistic trial (n=52) testing single IV infusions of ketamine (0.71 mg/kg), midazolam (0.025 mg/kg), dexmedetomidine (0.025 mg/kg), or saline in non-treatment-seeking smokers.

Target Enrollment
52 participants
Study Type
Phase I interventional
Design
Randomized, double Blind

Detailed Description

This randomized, double-blind, crossover study delivers single intravenous infusions of ketamine, midazolam, dexmedetomidine, or saline at least two weeks apart to assess effects on cigarette smoking behaviour, craving, withdrawal and neural measures.

Participants complete 7-day ecological momentary assessment (EMA) periods before and after each infusion, abstain for 24 hours post-infusion with next-day MRI and behavioural assessments, and are closely monitored for physical and subjective adverse effects.

Study Protocol

Preparation

sessions

Dosing

4 sessions

Integration

sessions

Study Arms & Interventions

Ketamine

experimental

Single IV ketamine infusion (0.71 mg/kg).

Interventions

  • Ketamine0.71 mg/kg
    via IV• single dose• 1 doses total

Midazolam

experimental

Single IV midazolam infusion (0.025 mg/kg).

Interventions

  • Compound0.025 mg/kg
    via IV• single dose• 1 doses total

    Midazolam 0.025 mg/kg

Dexmedetomidine

experimental

Single IV dexmedetomidine infusion (0.025 mg/kg).

Interventions

  • Compound0.025 mg/kg
    via IV• single dose• 1 doses total

    Dexmedetomidine 0.025 mg/kg

Saline (placebo)

inactive

Single IV saline infusion (placebo).

Interventions

  • Placebo
    via IV• single dose• 1 doses total

    Normal saline placebo

Participants

Ages
21 – 55
Sexes
Male & Female

Inclusion Criteria

  • Smokes cigarettes daily for at least 2 years
  • Afternoon expired breath carbon monoxide ≥5 ppm or morning urinary cotinine ≥100 ng/ml
  • Negative urine drug screen for psychoactive drugs and negative breath alcohol

Exclusion Criteria

  • Unstable medical condition or stable condition that would interact with study drug or participation (including chronic pulmonary disease, coronary artery disease, current brain tumour, increased intracranial pressure or impaired consciousness)
  • History of serious head trauma or neurological disorder (e.g., seizure disorder)
  • Hypertension (systolic >140 mm Hg and/or diastolic >90 mm Hg on three separate measures; systolic >170 or diastolic >110 on any occasion)
  • Pre-existing severe gastrointestinal narrowing (pathologic or iatrogenic)
  • Use of drugs that would interact with study drug or increase risk of adverse events
  • Pregnancy or lactation (among women)

Study Details

Locations

Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States

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