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NCT01943994 · ClinicalTrials.gov registry record · NA
Psilocybin-facilitated Smoking Cessation Treatment: A Pilot Study
A NA study, sponsored by Johns Hopkins University.
- Completed
- Registry status
- NA
- Development phase
- 82
- Enrollment target
NCT01943994: Completed NA study, sponsored by Johns Hopkins University.
NCT01943994 is a NA study that has completed, run by Johns Hopkins University. The registered enrollment target is 82 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01943994, a NA study, has completed, sponsored by Johns Hopkins University.
- COMPLETED
- Registry status
- NA
- Development phase
- 82 participants
- Enrollment target
Study Summary
One of the most promising lines of investigation for the therapeutic use of hallucinogens in the 1960s and 1970s was in the treatment of drug dependence. The investigators propose to examine psilocybin administration combined with a structured smoking cessation treatment program in nicotine dependent individuals in order to provide preliminary data on the efficacy of this combined treatment for smoking cessation. Prior work in the investigators laboratory has shown that under carefully prepared and supportive conditions, psilocybin administration can facilitate highly salient experiences with enduring personal meaning and spiritual significance. It is plausible that embedding such highly meaningful experiences into a drug dependence cessation attempt may provide an enduring motivation for remaining abstinent. Cigarette smoking is a good model system for studying drug dependence because users are less likely to be challenged by the many social and economic impairments that often accompany dependence on other drugs such as cocaine, heroin, or alcohol. More specifically, the investigators propose to conduct a randomized controlled comparative efficacy study in which either psilocybin or transdermal nicotine patch are administered under highly supportive conditions to individuals who are nicotine-dependent cigarette smokers, who have had multiple unsuccessful quit attempts, and who continue to desire to quit smoking. Other than nicotine dependence, participants will be healthy. Fifteen participants have already completed a preliminary open-label pilot-study with no control condition. Eighty additional participants will be enrolled and randomized to either psilocybin (n=40), or nicotine patch (n=40) treatment. Participants will receive a 13-week course of cognitive behavioral therapy for smoking cessation, with Target Quit Date set for week 5. After several preparation meetings with study monitors, participants will have either a single day-long psilocybin session using
Primary Outcome
Cigarette smoking abstinence from the target quit (allowing for an initial 14-day grace period) to the 6-month follow up, as verified by breath carbon monoxide, urine cotinine, and retrospective self-report.
Interventions
- DRUG Nicotine Replacement Therapy (NRT)
- DRUG Psilocybin-assisted treatment
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 82 participants |
| Start Date | 2008-09 |
| Est. Completion | 2023-11-14 |
| Phase | NA |
What the finished NCT01943994 record still lists
NCT01943994 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 82 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 2 interventions - of which Nicotine Replacement Therapy (NRT) is the first listed.
NCT01943994 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01943994 about?
NCT01943994 is a clinical study titled "Psilocybin-facilitated Smoking Cessation Treatment: A Pilot Study". One of the most promising lines of investigation for the therapeutic use of hallucinogens in the 1960s and 1970s was in the treatment of drug dependence. The investigators propose to examine psilocybin administration combined with a structured smoking cessation treatment program in nicotine dependen...
What is the current status of trial NCT01943994?
This trial is currently completed. It is a NA study. The enrollment target is 82 participants. The study started on 2008-09. Estimated completion is 2023-11-14.
What interventions are being tested in trial NCT01943994?
The interventions under investigation include: Nicotine Replacement Therapy (NRT) (DRUG), Psilocybin-assisted treatment (DRUG).
Who is sponsoring clinical trial NCT01943994?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01943994's enrollment target sits among peer trials
82 990th of 2000 higher than 1,009 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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