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NCT01986075 · ClinicalTrials.gov registry record · Phase 1

A Sequenced Behavioral and Medication Intervention for Cocaine Dependence

A Phase 1 study, sponsored by New York State Psychiatric Institute.

Completed
Registry status
Phase 1
Development phase
145
Enrollment target

NCT01986075: Completed Phase 1 study, sponsored by New York State Psychiatric Institute.

NCT01986075 is a Phase 1 study that has completed, run by New York State Psychiatric Institute. The registered enrollment target is 145 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (142% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01986075, a Phase 1 study, has completed, sponsored by New York State Psychiatric Institute.

COMPLETED
Registry status
Phase 1
Development phase
145 participants
Enrollment target

Study Summary

This study will investigate a treatment strategy in which a computer-assisted behavioral intervention will be used to help individuals stop their use of cocaine. A medication will be combined with the behavioral treatment among those individuals who do not respond to the behavioral intervention alone. The primary hypothesis of the study is that among cocaine dependent individuals who fail to respond to an initial trial of behavioral therapy, a greater proportion of individuals will benefit from the combined treatment (behavior therapy plus medication) compared to individuals in the comparison group.

Primary Outcome

The primary outcome measure will be a binary indicator (yes or no) of at least 3 consecutive weeks of urine toxicology confirmed self-reported abstinence during the last three weeks of the trial.

Interventions

  • DRUG Placebo
  • BEHAVIORAL Computer-assisted behavior therapy
  • DRUG Mixed-Amphetamine Salts- Extended Release (MAS-ER)

Trial Details

FieldValue
Enrollment Target 145 participants
Start Date 2014-01
Est. Completion 2021-01
Phase Phase 1

What the finished NCT01986075 record still lists

NCT01986075 is an interventional study that assigns participants to a tested intervention. The registered 145 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (142% higher).

The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.

NCT01986075 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01986075 about?

NCT01986075 is a clinical study titled "A Sequenced Behavioral and Medication Intervention for Cocaine Dependence". This study will investigate a treatment strategy in which a computer-assisted behavioral intervention will be used to help individuals stop their use of cocaine. A medication will be combined with the behavioral treatment among those individuals who do not respond to the behavioral intervention alon...

What is the current status of trial NCT01986075?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 145 participants. The study started on 2014-01. Estimated completion is 2021-01.

What interventions are being tested in trial NCT01986075?

The interventions under investigation include: Placebo (DRUG), Computer-assisted behavior therapy (BEHAVIORAL), Mixed-Amphetamine Salts- Extended Release (MAS-ER) (DRUG).

Who is sponsoring clinical trial NCT01986075?

This trial is sponsored by New York State Psychiatric Institute, which has 364 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01986075's enrollment target sits among peer trials

145 391st of 2000 higher than 1,607 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other 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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Source: ClinicalTrials.gov NCT01986075, the US trial registry maintained by the National Library of Medicine. NCT01986075 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.