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NCT03954938 · ClinicalTrials.gov registry record · Early Phase 1
Behavioral Effects of Drugs (Inpatient): 38
A Early Phase 1 study, sponsored by William Stoops.
- Terminated
- Registry status
- Early Phase 1
- Development phase
- 5
- Enrollment target
NCT03954938: Clinical Trial Early Phase 1 study, sponsored by William Stoops.
NCT03954938 is a Early Phase 1 study that was terminated before completion, run by William Stoops. The registered enrollment target is 5 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03954938, a Early Phase 1 study, was terminated before completion, sponsored by William Stoops.
- TERMINATED
- Registry status
- Early Phase 1
- Development phase
- 5 participants
- Enrollment target
Study Summary
The specific aim of this project is to demonstrate that the decisional analysis/craving regulation aspects of CBT reduce cocaine self-administration in subjects with cocaine use disorder through diminished craving responses. Thirty non-treatment seeking human subjects meeting diagnostic criteria for cocaine use disorder will complete an outpatient, crossover, placebo-controlled study consisting of 1 practice and 9 experimental sessions. In each experimental session, the reinforcing effects of intranasal cocaine will be determined under one of three regulation of craving conditions that simulate CBT decisional analysis (i.e., negative instruction, positive instruction or a neutral "look" condition). After sampling the dose of cocaine available in each session, subjects will complete the craving manipulation assigned to that session, they will then rate their craving and finally they will have the opportunity to earn the sampled dose in a progressive-ratio procedure. We hypothesize that focusing on the negative effects of cocaine use will decrease craving and reduce cocaine self-administration relative to the positive and "look" conditions, and that craving will be positively correlated with self-administration outcomes.
Primary Outcome
The reinforcing effects of cocaine were determined using a modified progressive ratio procedure (Stoops et al., 2010) in which subjects can make 5 choices for each available cocaine dose. Reinforcing effects were measured for each cocaine dose during across the craving manipulation conditions.
Interventions
- DRUG Placebo
- DRUG Cocaine
- BEHAVIORAL Craving Manipulation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2019-05-15 |
| Est. Completion | 2021-12-03 |
| Phase | Early Phase 1 |
Why NCT03954938 stopped before completion
NCT03954938 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (91% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT03954938 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03954938 about?
NCT03954938 is a clinical study titled "Behavioral Effects of Drugs (Inpatient): 38". The specific aim of this project is to demonstrate that the decisional analysis/craving regulation aspects of CBT reduce cocaine self-administration in subjects with cocaine use disorder through diminished craving responses. Thirty non-treatment seeking human subjects meeting diagnostic criteria for...
What is the current status of trial NCT03954938?
This trial is currently terminated. It is a Early Phase 1 study. The enrollment target is 5 participants. The study started on 2019-05-15. Estimated completion is 2021-12-03.
What interventions are being tested in trial NCT03954938?
The interventions under investigation include: Placebo (DRUG), Cocaine (DRUG), Craving Manipulation (BEHAVIORAL).
Who is sponsoring clinical trial NCT03954938?
This trial is sponsored by William Stoops, which has 13 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03954938's enrollment target sits among peer trials
5 1887th of 2000 higher than 80 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 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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