Phase 4
Completed N=112
Lamotrigine add-on Therapy for Bipolar Disorder and Cocaine Dependency
Bipolar Disorder · Cocaine Dependence
Source: ClinicalTrials.gov NCT00280293 ↗
Enrolled (actual)
112
Serious AEs
8.0%
Results posted
Sep 2013
Primary outcomePrimary: Days of Cocaine Use — 1.8; 2.8 days
Summary
The purpose of this study is to determine if lamotrigine add-on therapy is associated with decreased cocaine craving and improvement in depressive symptom severity than placebo in a group of outpatients with bipolar disorder and cocaine dependence. Additionally, this study is examining whether lamotrigine add-on therapy is associated with decreased cocaine use and the improvement of manic symptom severity than placebo in a group of outpatients with bipolar disorder and cocaine dependence.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Days of Cocaine Use |
1.8; 2.8 | — |
| PRIMARY Positive Urine Drug Screens |
67.3; 73.6 | — |
| SECONDARY Depression Score on the Hamilton Rating Scale For Depression |
13.4; 13.6 | — |
| SECONDARY Dollars Spent |
68.6; 155.4 | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of bipolar I, II, not otherwise specified or cyclothymic disorders
- Currently depressed or mixed mood state
- Ages 18-70 years
- Men or women
- Self-reported cocaine use within 14 days prior to randomization
- English or Spanish speaking
- Baseline Hamilton Depression Rating Scale (HRSD17) score ≥ 10
Exclusion Criteria
- Currently taking an enzyme inducing or inhibiting anticonvulsant (e.g. valproic acid, carbamazepine)
- Current severe psychotic features (e.g. daily auditory hallucinations, fixed delusions, severely disorganized thought processes) that require antipsychotic therapy, and that do not appear to be secondary to cocaine use
- Active suicidal ideation (plan and intent) or ≥2 attempts in past 12 months or any attempt in the past month
- Highly unstable medical condition
- Change in concomitant psychiatric medications (e.g. initiated antipsychotic) or in other substance abuse treatment (e.g. began intensive outpatient treatment) within 7 days prior to study entry
- Vulnerable populations (e.g. pregnant or nursing women, prisoners, mentally retarded)
Data sourced from ClinicalTrials.gov (NCT00280293). 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.