Phase 2
Completed N=43
Treatment of Cocaine Dependence With Lisdexamfetamine
Cocaine Dependence
Source: ClinicalTrials.gov NCT00958282 ↗
Enrolled (actual)
43
Serious AEs
4.7%
Results posted
Sep 2015
Primary outcomePrimary: Cocaine-positive Urine Results — 86.5; 92.4 percentage of BE urine tests
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cocaine-positive Urine Results |
86.5; 92.4 | — |
| SECONDARY Drug Craving |
17.5; 28.7 | — |
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.
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. Informational only — not medical advice.