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NCT02538744 · ClinicalTrials.gov registry record · Phase 1

Complementary Combination Therapy for Cocaine Dependence

A Phase 1 study of Cocaine Dependence, sponsored by Baylor College of Medicine.

Completed
Registry status
Phase 1
Development phase
45
Enrollment target
1
Study location

NCT02538744: Completed Phase 1 study of Cocaine Dependence, sponsored by Baylor College of Medicine.

NCT02538744 is a Phase 1 study of Cocaine Dependence that has completed, run by Baylor College of Medicine. The registered enrollment target is 45 participants, below the 297-participant average among 38 other Cocaine Dependence trials with a reported enrollment target (85% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02538744, a Phase 1 study of Cocaine Dependence, has completed, sponsored by Baylor College of Medicine.

COMPLETED
Registry status
Phase 1
Development phase
45 participants
Enrollment target
1
Study location

Study Summary

The investigators will assess the impact of treatment with doxazosin and modafinil, alone and in combination, on the subjective and reinforcing effects of cocaine in non-treatment-seeking, cocaine-dependent volunteers. The investigators will use a hybrid design in which participants will be randomized into two groups: placebo and doxazosin 8 mg/d. They will remain in their assigned group for the duration of the study. After titrating doxazosin to the target dose, study procedures will be completed three times, once during treatment with each dose of modafinil (0, 200, and 300 mg/d), in pseudo-random order such that 200 mg precedes 300 mg).

Primary Outcome

difference between the peak "High" VAS rating observed post-cocaine infusion and that observed at baseline prior to the infusion

Conditions Studied

Interventions

  • DRUG Placebo
  • DRUG Doxazosin
  • DRUG Modafinil
  • DRUG cocaine

Study Locations (1)

Texas

  • Michael Debakey VA Medical Center - Houston

Trial Details

FieldValue
Enrollment Target 45 participants
Start Date 2015-08
Est. Completion 2018-08-21
Phase Phase 1
Baylor College of Medicine

616 total trials

What the finished NCT02538744 record still lists

NCT02538744 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 45 participants, a relatively small participant target, below the 297-participant average among 38 other Cocaine Dependence trials with a reported enrollment target (85% lower).

The record links to 1 condition, with Cocaine Dependence appearing as the primary indexed condition, and to 4 interventions - of which Placebo is the first listed.

NCT02538744 reports a single indexed study location in Texas.

Frequently Asked Questions

What is clinical trial NCT02538744 about?

NCT02538744 is a clinical study titled "Complementary Combination Therapy for Cocaine Dependence". The investigators will assess the impact of treatment with doxazosin and modafinil, alone and in combination, on the subjective and reinforcing effects of cocaine in non-treatment-seeking, cocaine-dependent volunteers. The investigators will use a hybrid design in which participants will be randomiz...

What is the current status of trial NCT02538744?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 45 participants. The study started on 2015-08. Estimated completion is 2018-08-21.

What conditions does trial NCT02538744 study?

This clinical trial studies the following conditions: Cocaine Dependence.

What interventions are being tested in trial NCT02538744?

The interventions under investigation include: Placebo (DRUG), Doxazosin (DRUG), Modafinil (DRUG), cocaine (DRUG).

Who is sponsoring clinical trial NCT02538744?

This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02538744 being conducted?

This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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 NCT02538744's enrollment target sits among peer trials

45 25th of 38 higher than 13 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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Source: ClinicalTrials.gov NCT02538744, the US trial registry maintained by the National Library of Medicine. NCT02538744 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.