Reinforcing Effects of Cocaine During Phendimetrazine Maintenance

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2018-12-31

Brief Summary

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This study will determine the initial efficacy of phendimetrazine as a pharmacotherapy for cocaine dependence. A rigorous, inpatient human laboratory study will be conducted in which the subjective, physiological and reinforcing effects of cocaine are evaluated during maintenance on placebo and phendimetrazine.

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Detailed Description

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Conditions

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Cocaine Use Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Placebo

Subjects will be maintained on oral placebo, administered twice daily for approximately two weeks. Cocaine will be administered acutely during placebo maintenance. Placebo will be administered acutely during placebo maintenance.

Group Type PLACEBO_COMPARATOR

Cocaine

Intervention Type DRUG

Intranasal cocaine will be administered during experimental sessions.

Placebo

Intervention Type DRUG

Placebo capsules will contain only cornstarch.

Phendimetrazine

Subjects will be maintained on oral phendimetrazine (up to 210 mg/day) administered twice daily for approximately two weeks. Cocaine will be administered acutely during placebo maintenance. Placebo will be administered acutely during placebo maintenance.

Group Type EXPERIMENTAL

Phendimetrazine

Intervention Type DRUG

Phendimetrazine will be administered in divided doses twice daily.

Cocaine

Intervention Type DRUG

Intranasal cocaine will be administered during experimental sessions.

Interventions

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Phendimetrazine

Phendimetrazine will be administered in divided doses twice daily.

Intervention Type DRUG

Cocaine

Intranasal cocaine will be administered during experimental sessions.

Intervention Type DRUG

Placebo

Placebo capsules will contain only cornstarch.

Intervention Type DRUG

Other Intervention Names

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Bontril

Eligibility Criteria

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Inclusion Criteria

* Recent cocaine use

Exclusion Criteria

* Abnormal screening outcome (e.g., ECG, blood chemistry result) that study physicians deem clinically significant
* Current or past histories of substance abuse or dependence that are deemed by the study physicians to interfere with study completion
* History of serious physical disease, current physical disease, impaired cardiovascular functioning, chronic obstructive pulmonary disease, history of seizure or current or past histories of serious psychiatric disorder that in the opinion of the study physician would interfere with study participation will be excluded from participation
* Females not currently using effective birth control
* Contraindications to cocaine or phendimetrazine

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes