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NCT01267292 · ClinicalTrials.gov registry record · Phase 2
Psychopharmacology for Cocaine Dependence - Buspirone
A Phase 2 study, sponsored by The University of Texas Health Science Center, Houston.
- Completed
- Registry status
- Phase 2
- Development phase
- 50
- Enrollment target
NCT01267292: Completed Phase 2 study, sponsored by The University of Texas Health Science Center, Houston.
NCT01267292 is a Phase 2 study that has completed, run by The University of Texas Health Science Center, Houston. The registered enrollment target is 50 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01267292, a Phase 2 study, has completed, sponsored by The University of Texas Health Science Center, Houston.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 50 participants
- Enrollment target
Study Summary
Chronic cocaine use may produce disruption of neurotransmitter functions (including dopamine). This may in turn contribute to measurable dysfunction in important cognitive and behavioral processes. Stimulants that enhance dopamine (DA) function may help in treating cocaine dependence and improving behavioral function -- supporting the notion that these processes are related. An important step is to understand the subjective, physiological, and behavioral effects of potential medications for cocaine dependence. DA-modulating drugs may be targets for pharmacotherapy for substance dependence, and particularly for stimulant drugs like cocaine, which disrupt normal DA function. Buspirone is currently the only available dopamine subtype 3 (DA3) approved for human administration, and is thus a viable investigational compound. This project proposes to evaluate the DA-modulating effects of buspirone on behavioral deficiencies related to DA depletion. Accordingly, the project aims to characterize the effects of buspirone in individuals with cocaine dependence. Employing a daily dosing designs within an acute stimulant challenge (methylphenidate), the experiment will characterize the subjective effects, cardiovascular effects, and behavioral effects (attentional bias to drug cues and risky decision making). The primary hypotheses are that buspirone will attenuate the increases in subjective drug effects ("stimulated", "like drug") and behavioral effects (increases in attentional bias and risky decision making) that are produced by acute methylphenidate administration.
Primary Outcome
The mean score over all 4 time points is reported in this outcome measure (i.e., a summary score is reported). Each subject contributed 1 data point for each dose level of Methylphenidate (15mg, 30mg, 60mg, or 0mg), resulting in a total of 20 data points per dose level per arm. The Stroop task assesses attentional biases to cocaine-related (drug-related) and rewarding (non-drug related) stimuli vs. neutral stimuli. Participants are instructed to respond to words shown in different colors on the
Interventions
- DRUG Methylphenidate
- DRUG Buspirone
- DRUG Placebo for Buspirone
- DRUG Placebo for Methylphenidate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2011-03 |
| Est. Completion | 2015-12 |
| Phase | Phase 2 |
What the finished NCT01267292 record still lists
NCT01267292 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (62% lower).
The record links to 0 conditions, and to 4 interventions - of which Methylphenidate is the first listed.
NCT01267292 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01267292 about?
NCT01267292 is a clinical study titled "Psychopharmacology for Cocaine Dependence - Buspirone". Chronic cocaine use may produce disruption of neurotransmitter functions (including dopamine). This may in turn contribute to measurable dysfunction in important cognitive and behavioral processes. Stimulants that enhance dopamine (DA) function may help in treating cocaine dependence and improving b...
What is the current status of trial NCT01267292?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 50 participants. The study started on 2011-03. Estimated completion is 2015-12.
What interventions are being tested in trial NCT01267292?
The interventions under investigation include: Methylphenidate (DRUG), Buspirone (DRUG), Placebo for Buspirone (DRUG), Placebo for Methylphenidate (DRUG).
Who is sponsoring clinical trial NCT01267292?
This trial is sponsored by The University of Texas Health Science Center, Houston, which has 732 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01267292's enrollment target sits among peer trials
50 1195th of 2000 higher than 740 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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