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NCT01811940 · ClinicalTrials.gov registry record · Phase 2
Multicenter Trial of Combined Pharmacotherapy to Treat Cocaine Dependence
A Phase 2 study of Cocaine Dependence, sponsored by New York State Psychiatric Institute.
- Completed
- Registry status
- Phase 2
- Development phase
- 169
- Enrollment target
- 2
- Study locations
NCT01811940: Completed Phase 2 study of Cocaine Dependence, sponsored by New York State Psychiatric Institute.
NCT01811940 is a Phase 2 study of Cocaine Dependence that has completed, run by New York State Psychiatric Institute. The registered enrollment target is 169 participants, below the 294-participant average among 38 other Cocaine Dependence trials with a reported enrollment target (43% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01811940, a Phase 2 study of Cocaine Dependence, has completed, sponsored by New York State Psychiatric Institute.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 169 participants
- Enrollment target
- 2
- Study locations
Study Summary
The proposed protocol is a multi-site double-blind, placebo-controlled outpatient study of the safety and efficacy of Adderall-XR (MAS-ER) and topiramate in the treatment of cocaine dependence. 198 patients will be enrolled and 176 patients randomized in a 14-week trial. The proportion of participants achieving sustained cocaine abstinence for three consecutive weeks at the end of the study will be significantly greater for the combined pharmacotherapies group compared to the placebo group.
Primary Outcome
The number of participants in each study arm achieving sustained cocaine abstinence for three consecutive weeks at the end of the study. This will be measured by self reported cocaine use on the daily Time line Follow Back (TLFB) and corroborated by the urine toxicology samples collected 3 times per week.
Conditions Studied
Interventions
- OTHER Placebo
- DRUG Topiramate
- DRUG Adderall-ER
Study Locations (2)
New York
- STARS - New York
Pennsylvania
- University of Pennsylvania - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 169 participants |
| Start Date | 2013-07 |
| Est. Completion | 2017-06 |
| Phase | Phase 2 |
What the finished NCT01811940 record still lists
NCT01811940 is an interventional study that assigns participants to a tested intervention. The registered 169 participants enrollment target is mid-sized for trials with a published cap, below the 294-participant average among 38 other Cocaine Dependence trials with a reported enrollment target (43% lower).
The record links to 1 condition, with Cocaine Dependence appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT01811940 reports a single indexed study location in New York, Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT01811940 about?
NCT01811940 is a clinical study titled "Multicenter Trial of Combined Pharmacotherapy to Treat Cocaine Dependence". The proposed protocol is a multi-site double-blind, placebo-controlled outpatient study of the safety and efficacy of Adderall-XR (MAS-ER) and topiramate in the treatment of cocaine dependence. 198 patients will be enrolled and 176 patients randomized in a 14-week trial. The proportion of participan...
What is the current status of trial NCT01811940?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 169 participants. The study started on 2013-07. Estimated completion is 2017-06.
What conditions does trial NCT01811940 study?
This clinical trial studies the following conditions: Cocaine Dependence.
What interventions are being tested in trial NCT01811940?
The interventions under investigation include: Placebo (OTHER), Topiramate (DRUG), Adderall-ER (DRUG).
Who is sponsoring clinical trial NCT01811940?
This trial is sponsored by New York State Psychiatric Institute, which has 364 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01811940 being conducted?
This trial has 2 study locations across New York, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Cocaine Dependence
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01811940's enrollment target sits among peer trials
169 8th of 38 higher than 31 of 38 other Cocaine Dependence trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cocaine Dependence 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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