Phase 2
Completed N=81
Medications for Stopping Cocaine Dependence and Preventing Relapse
Cocaine Abuse · Cocaine-Related Disorders
Source: ClinicalTrials.gov NCT00218023 ↗
Enrolled (actual)
81
Serious AEs
8.6%
Results posted
Apr 2017
Primary outcomePrimary: Mean Percentage of Cocaine-positive Urines Over Course of 12 Week Treatment in Subgroup Achieving Abstinence at Baseline — 31; 28; 47; 35 Mean % of cocaine-positive urines
Summary
Cocaine dependence is a major public health problem; an effective primary treatment for cocaine dependent individuals has yet to be found. The purpose of this study is to identify subpopulations and baseline conditions that are most responsive to treatment for cocaine dependent individuals.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Percentage of Cocaine-positive Urines Over Course of 12 Week Treatment in Subgroup Achieving Abstinence at Baseline |
31; 28; 47; 35 | — |
| PRIMARY Mean Percentage of Cocaine-positive Urines Over Course of 12 Week Treatment in Subgroup NOT Achieving Abstinence at Baseline |
88; 49; 62; 91 | — |
Eligibility Criteria
Inclusion Criteria
- Meets DSM-IV criteria for current cocaine dependence
Exclusion Criteria
- Meet diagnostic criteria for other serious psychiatric symptoms and/or disorders that would interfere with participation in the treatment study (e.g., psychosis; mania; suicidal/ homicidal ideation) including other forms of drug dependence, nicotine and cannabis excepted.
- Medical conditions contraindicating naltrexone therapy (e.g., past history of opioid use in the 30 days prior to study entry or significant hepatocellular injury)
- Medical conditions contraindicating modafinil therapy (e.g., hypertension, seizures, arrhythmia, or coronary artery disease)
- Medical conditions contraindicating levodopa/carbidopa therapy (e.g., severe pulmonary/cardiovascular disease, narrow angle glaucoma, melanoma, history of peptic ulcer, or renal function impairment)
- Requires certain medications
- Current or recent treatment for substance use or other psychiatric condition
- On parole or probation that requires reports of drug use to officers of the court
- Pending incarceration
- Pregnant or breastfeeding
- Unable to read, write, or speak English
- Plans to leave the study area within 3 months of study entry
Data sourced from ClinicalTrials.gov (NCT00218023). 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.