Treatment of Cocaine Dependence With Lisdexamfetamine

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2013-01-31

Brief Summary

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This protocol is a 2-group double-blind placebo-controlled outpatient study investigating lisdexamfetamine for treatment of cocaine dependence. The investigators plan to enroll 100 subjects in a 14-week trial. The primary objectives will determine changes in cocaine use and secondary objectives will be cocaine craving and impulsivity.

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Detailed Description

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This 2-group, double-blind, placebo-controlled, 14-week study (N=100) will investigate the efficacy of cognitive behavioral therapy plus lisdexamfetamine vs. placebo to treat cocaine dependence. We hypothesize that lisdexamfetamine will reduce cocaine use (primary outcome), as well as cocaine craving and impulsivity (secondary outcomes) vs. placebo.

Conditions

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Cocaine Dependence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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lisdexamfetamine/Behavior Therapy

lisdexamfetamine 70mg/day plus Behavior Therapy

Group Type ACTIVE_COMPARATOR

lisdexamfetamine/Behavior Therapy

Intervention Type DRUG

placebo

Placebo Comparator once per day

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type OTHER

Interventions

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lisdexamfetamine/Behavior Therapy

Intervention Type DRUG

placebo

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Eligible participants must:

1. Be treatment-seeking males or females between 18 and 65 years-of-age;
2. Understand the study procedures and provide written informed consent;
3. Be judged by the examining physician to be in generally good health with the exception of health problems related to acute drug use;
4. Meet DSM-IV criteria for cocaine-dependence.

Exclusion Criteria

1. DSM-IV diagnoses for current psychotic disorders, mood disorders (except substance-induced depression), anxiety disorders, ADHD, and other current substance dependence (except marijuana and nicotine dependence); subjects may not have physiological dependence upon alcohol requiring medical detoxification;
2. Current use of any prescription medications;
3. Females currently pregnant or nursing;
4. Current elevation of liver enzyme levels above twice normal limits;
5. Existing cardiovascular disease as determined by physician, EKG evaluation;
6. History of significant acute or chronic physical illness precluding participation;
7. History of hyperthyroidism, glaucoma, or seizures.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No