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Complementary Combination Therapy for Cocaine Dependence

NCT02538744 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2022-04-26

No results posted yet for this 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).

Conditions

  • Cocaine Dependence

Interventions

DRUG

Doxazosin

Participants will be randomized into two groups: placebo and doxazosin 8 mg/d. The doxazosin dose will be increased every 4 days over 11 days, starting with 1mg on the first study day and and ending with 8mg 11 days later. Participants will receive one capsule daily that will contain either placebo or doxazosin.

DRUG

Modafinil

After titrating doxazosin to the target dose, study procedures will be completed three times, once during treatment with each dose of modafinil (0 \[placebo\], 200, and 300 mg/d), in pseudo-random order such that 200 mg precedes 300 mg).

DRUG

cocaine

On the 5th day of study medication treatment participants will receive non-contingent doses of cocaine (placebo, 20, 40 mg, IV) and participate in cocaine self-administration sessions.

DRUG

Placebo

Sponsors & Collaborators

  • Baylor College of Medicine

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-31
Primary Completion
2018-08-21
Completion
2018-08-21

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02538744 on ClinicalTrials.gov