Full Text View
Tabular View
No Study Results Posted
Related Studies
Medications for Stopping Cocaine Dependence and Preventing Relapse
This study is currently recruiting participants.
Study NCT00218023   Information provided by National Institute on Drug Abuse (NIDA)
First Received: September 16, 2005   Last Updated: April 7, 2009   History of Changes

September 16, 2005
April 7, 2009
March 2006
March 2010   (final data collection date for primary outcome measure)
Confirmed abstinence from cocaine [ Time Frame: 12 weeks of treatment ] [ Designated as safety issue: No ]
Self reported cocaine use
Complete list of historical versions of study NCT00218023 on ClinicalTrials.gov Archive Site
 
Cocaine withdrawal, craving, negative effect, medication compliance, side effects
 
Medications for Stopping Cocaine Dependence and Preventing Relapse
Screening Medications for Cocaine Cessation and Relapse Prevention

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.

Cocaine is a strong central nervous system stimulant that is widely abused throughout the United Sates. Due to its widespread use, it is important to develop an effective treatment for cocaine dependence. Motivational Interviewing (MI) is often effective when combined with drug treatment. Baseline condition (e.g., abstinence status) and population type (e.g., ethnicity and gender) often affect how an individual responds to treatment for drug dependence. The purpose of this study is to determine the influence of baseline status and population type on treatment response in cocaine dependent individuals. In addition, this study will examine how various cocaine abuse medications target different neuronal systems, withdrawal symptoms, and relapse to drug use.

This study will take place in two phases. Phase I will last 4 weeks; participants will receive MI and undergo contingency-based urine tests in order to achieve the desired baseline condition. Phase II will last 12 weeks. Participants in Phase II will be randomly assigned to receive one of four treatments: 1) 50 mg naltrexone, 2) 800/200 mg levodopa/carbidopa, 3) 400 mg modafinil, or 4) placebo. During Phase II, all participants will receive psychotherapy and contingency management. Participants will complete urine drug screening tests 3 times each week. Follow-up study visits will occur between 3 and 6 months following Week 12, and will include objective and self-reported drug use.

Phase II
Interventional
Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
  • Cocaine Abuse
  • Cocaine-Related Disorders
  • Drug: Naltrexone
  • Drug: Modafinil
  • Drug: Levodopa/Carbidopa
  • Drug: Placebo
  • Experimental: Naltrexone hydrochloride , 50mg per day
  • Experimental: Levodopa/carbidopa, 800/200 mg per day
  • Experimental: Modafinil 200mg
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
200
March 2011
March 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 55 Years
Yes
Contact: Jan Lindsay, Ph.D. 713-500-2563 jan.a.lindsay@uth.tmc.edu
Contact: Ann Garcia, MA 713-500-2804 Ann.D.Garcia@uth.tmc.edu
United States
 
NCT00218023
Joy Schmitz, Ph.D., University of Texas Medical School at Houston
NIDA-09262-7, P50-DA009262-7, DPMC
National Institute on Drug Abuse (NIDA)
University of Texas
Principal Investigator: Joy Schmitz, PhD University of Texas
National Institute on Drug Abuse (NIDA)
April 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP