Phase 2
Completed N=50
Evaluation of Atomoxetine for Cocaine Dependence: A Pilot Trial
Substance Abuse
Source: ClinicalTrials.gov NCT00617201 ↗
Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Dec 2012
Primary outcomePrimary: % Urine Samples Negative for Cocaine — .67; .74 percentage of positive urine samples
Summary
This placebo-controlled, double-blind, randomized pilot clinical trial will evaluate atomoxetine (Strattera®) for the treatment of cocaine dependence. Cocaine-dependent individuals, who are healthy and are seeking treatment for their substance abuse, will be randomized to receive either atomoxetine (n=25) or a matched-placebo (n=25) during a trial lasting 12 weeks; there will be a double-blind, ascending dose lead-in order to achieve maintenance on the assigned active dose safely. Contingency management procedures will be used to reinforce attendance and compliance with study procedures. Primary outcome measures will include urinalysis data assessing cocaine use.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY % Urine Samples Negative for Cocaine |
.67; .74 | — |
| SECONDARY Retention |
57.4; 51.6 | — |
Eligibility Criteria
Inclusion Criteria
- Seeking treatment for cocaine dependence
- Must have used cocaine in the past 30 days
Exclusion Criteria
- Physical dependence on any drug requiring medical management
- Any major medical or psychiatric disorder that would be contraindicated for participation
- Cardiovascular disease
- Seizures or significant head injuries
- Currently taking atomoxetine
- Pregnant or breast-feeding
Data sourced from ClinicalTrials.gov (NCT00617201). 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.