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

NCT ID: NCT02383043

Last Updated: 2019-04-11

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-01

Study Completion Date

2018-04-05

Brief Summary

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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.

Detailed Description

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Conditions

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Active Cocaine Users

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Active Treatment

Cocaine choice during d-amphetamine maintenance

Group Type EXPERIMENTAL

Cocaine

Intervention Type DRUG

Sustained Release d-Amphetamine

Intervention Type DRUG

Placebo Treatment

Cocaine choice during placebo maintenance

Group Type PLACEBO_COMPARATOR

Cocaine

Intervention Type DRUG

Sustained Release d-Amphetamine

Intervention Type DRUG

Interventions

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Cocaine

Intervention Type DRUG

Sustained Release d-Amphetamine

Intervention Type DRUG

Other Intervention Names

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Dexedrine Spansule SR

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Joshua A. Lile, Ph.D.

OTHER

Sponsor Role lead

Responsible Party

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Joshua A. Lile, Ph.D.

Joshua A. Lile, Ph.D., Associate Professor of Behavioral Science

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Laboratory of Human Behavioral Pharmacology

Lexington, Kentucky, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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R01DA033364-02

Identifier Type: NIH

Identifier Source: org_study_id

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