Impact of a Non-Drug Choice on Cocaine Reinforcement

Joshua A. Lile, Ph.D.

Status and phase: Completed; Early Phase 1

Conditions: Cocaine Dependence

Treatments: Drug: Placebo; Drug: Cocaine

Study type: Interventional

Funder types: Other

Identifiers

NCT01906346

R01DA033364-01

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 self-administration procedures and a non-drug alternative reinforcer, which is hypothesized to reduce the reinforcing effects of cocaine.

Enrollment: 9 patients

Sex: All

Ages: 21 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Cocaine dependence, 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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9 participants in 3 patient groups

Low Value Alternative Reinforcer

Experimental group

Description:

A low value reinforcer will be made available as an alternative to cocaine and placebo.

Treatment:

Drug: Placebo

Drug: Cocaine

Medium Value Reinforcer

Experimental group

Description:

A medium value reinforcer will be made available as an alternative to cocaine and placebo.

Treatment:

Drug: Placebo

Drug: Cocaine

High Value Reinforcer

Experimental group

Description:

A high value reinforcer will be made available as an alternative to cocaine and placebo.

Treatment:

Drug: Placebo

Drug: Cocaine