Impact of Sustained Release d-Amphetamine on Choice Between Cocaine and a Non-Drug Reinforcer

Joshua A. Lile, Ph.D.

Status and phase: Completed; Early Phase 1

Conditions: Active Cocaine Users

Treatments: Drug: Cocaine; Drug: Sustained Release d-Amphetamine

Study type: Interventional

Funder types: Other

Identifiers

NCT02383043

R01DA033364-02

Details and patient eligibility

About

Cocaine-use disorders continue to be a significant public health concern, yet no effective medications have been identified. The goal of this study is to establish a research platform for the development of medications for treatment of cocaine abuse and dependence. This study will incorporate choice self-administration procedures between drug and a non-drug alternative reinforcer presented during maintenance on d-amphetamine, which has been previously shown to reduce cocaine use.

Enrollment: 18 patients

Sex: All

Ages: 21 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Recent cocaine use, otherwise healthy

Exclusion criteria

• Laboratory results outside of clinically acceptable ranges, history of or current serious physical or psychiatric disease

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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18 participants in 2 patient groups, including a placebo group

Active Treatment

Experimental group

Description:

Cocaine choice during d-amphetamine maintenance

Treatment:

Drug: Sustained Release d-Amphetamine

Drug: Cocaine

Placebo Treatment

Placebo Comparator group

Description:

Cocaine choice during placebo maintenance

Treatment:

Drug: Sustained Release d-Amphetamine

Drug: Cocaine