The purpose of this trial is to identify subpopulations and baseline conditions that are most responsive to treatment, in order to facilitate decision-making regarding medication administration.

Condition	Intervention	Phase
Cocaine Abuse Cocaine-Related Disorders	Drug: Naltrexone	Phase II

Further Study Details: 

Primary Outcomes: Self reported cocaine use
Secondary Outcomes: Cocaine withdrawal, craving, negative effect, medication compliance, side effects
Expected Total Enrollment:  200

This is a double-blind, randomized, placebo-controlled trial to determine the influence of baseline status (abstinent versus non-abstinent) on the effectiveness of pharmacotherapy in cocaine dependence; to select agents targeting different neuronal systems while determining the differential effects on cocaine dependence treatment, withdrawal symptoms and relapse prevention; to determine which secondary facotrs (demographic/motivational/abuse pattern) predict achievement of initial abstinence and response to MI intervention. During Phase I (4 weeks duration), treatment seeking cocaine users will undergo motivational interviewing and contingency-based urine testing in order to achieve baseline abstinence. Phase II subsequently stratifies subjects to abstinence status and randomly assigns them to 1 of 4 pharmacotherapies (placebo, naltrexone 50 mg, levodopa/carbidopa 800/200 mg, modafinil 400 mg). During Phase II treatment (12 weeks) all participants will receive psychotherapy and contingency management to enhance compliance, with urine screening tests 3 times each week. Objective and self-reported drug use will continue to be measured for 3-6 months following treatment.

Ages Eligible for Study:  18 Years   -   55 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Meets DSM-IV criteria for current cocaine dependence
• At least 1 positive urine BE test (greater than 300 ng/mL) during Phase I of study
• Provide the names of at least 2 people who can generally locate their whereabouts

Exclusion Criteria:

• Current DSM-IV diagnosis of any psychoactive substance dependence other than cocaine, marijuana or nicotine
• DSM-IV axis I psychiatric disorder or neurological disease or other disorder requiring ongoing treament and/or that makes study participation unsafe
• Significant current suicidal or homicidal ideation
• Medical condition contraindicating naltrexone therapy (e.g., past history of opioid abuse within the 30 days prior to enrollment, significant hepatocellular injury)
• Medical conditions contraindicating modafinil therapy (e.g., high blood pressure, seizures, arrhythmia, CAD)
• Medical conditions contraindicating L-dopamine/carbidopa therapy (e.g., severe pulmonary/cardiovascualr disease, narrow angle glaucoma, melanoma, history of peptic ulcers, kidney function impairment)
• Taking medications known to have significant drug interactions with study medications (e.g., opiate-containing pain-medications, MAO inhibitors, anticonvulsants, haloperidol, phenothiazines, selegiline, anesthetics)
• Current or recent (within the 3 months prior to enrollment) treatment for substance use or another psychiatric condition
• Conditions of parole/probation requiring 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 immediate geographical area within 3 months following enrollment

Please refer to this study by ClinicalTrials.gov identifier  NCT00218023

Ayesha Chawdhary, B.A.      (713)500-2820    ayesha.chawdhary@uth.tmc.edu

Texas
      University of Texas Health Science Center, San Antonio,  Texas,  78284,  United States

Study chairs or principal investigators

John Grabowski, Ph.D.,  Principal Investigator,  University of Texas   

Study ID Numbers:  NIDA-09262-7; P50-09262-7
Last Updated:  September 21, 2005
Record first received:  September 16, 2005
ClinicalTrials.gov Identifier:  NCT00218023
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-09-27