Phase 2 N=43 Randomized Quadruple-blind Treatment

Treatment of Cocaine Dependence With Lisdexamfetamine

Cocaine Dependence

Bottom Line

View on ClinicalTrials.gov: NCT00958282 ↗

Enrolled (actual)

Serious AEs

4.7%

Results posted

Sep 2015

Primary outcome: Primary: Cocaine-positive Urine Results — 86.5; 92.4 percentage of BE urine tests

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: lisdexamfetamine/Behavior Therapy (Drug); placebo (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Minnesota
Primary completion: Jan 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Cocaine-positive Urine Results	86.5; 92.4	—
SECONDARY Drug Craving	17.5; 28.7	—

Summary

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.

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

Exclusion criteria include:
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;
Current use of any prescription medications;
Females currently pregnant or nursing;
Current elevation of liver enzyme levels above twice normal limits;
Existing cardiovascular disease as determined by physician, EKG evaluation;
History of significant acute or chronic physical illness precluding participation;
History of hyperthyroidism, glaucoma, or seizures.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00958282). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.