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Medications for Stopping Cocaine Dependence and Preventing Relapse

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2009 by National Institute on Drug Abuse (NIDA).
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by:
National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
NCT00218023
First received: September 16, 2005
Last updated: December 11, 2009
Last verified: December 2009

September 16, 2005
December 11, 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
Not Provided
Cocaine withdrawal, craving, negative effect, medication compliance, side effects
Not Provided
Not Provided
 
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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Cocaine Abuse
  • Cocaine-Related Disorders
  • Drug: Naltrexone
    Naltrexone hydrochloride 50mg per day, A 2-day dose run up procedure starting at 25mg and increasing by 25 mg will be followed by a fixed daily dose administered as 25 mg bid. Subjects will be instructed to take one pill by mouth twice a day and to continue to do so throughout the 12-week treatment phase of the study.
    Other Name: Naltrexon hydrochloride
  • Drug: Modafinil
    A 2-day dose run up procedure starting at 200 mg modafinil per day will be followed by a fixed daily dose administered as 400 mg/day.
    Other Name: Provigil
  • Drug: Levodopa/Carbidopa
    Levodopa/carbidopa, 800/200 mg per day, in the sustained release formulation (Sinemet CR) will be the pharmacotherapy in this condition. A 2-day dose run up procedure starting at 400mg l-dopa and 100 mg carbidopa per day will be followed by a fixed daily dose administered as 400/100 bid
    Other Name: Simemet CR
  • Drug: Placebo
    Placebo
    Other Name: Placebo
  • Experimental: 1
    Naltrexone hydrochloride , 50mg per day
    Intervention: Drug: Naltrexone
  • Experimental: 2
    Levodopa/carbidopa, 800/200 mg per day
    Intervention: Drug: Levodopa/Carbidopa
  • Experimental: 3
    Modafinil 200mg
    Intervention: Drug: Modafinil
  • Placebo Comparator: 4
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) 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: Laura B Madden-Fuentes, B.A. 713-500-2563 Laura.MaddenFuentes@uth.tmc.edu
Contact: Ann Garcia, MA 713-500-2804 Ann.D.Garcia@uth.tmc.edu
United States
 
NCT00218023
NIDA-09262-7, P50DA009262-07, DPMC
Yes
Joy Schmitz, Ph.D., University of Texas Medical School at Houston
University of Texas
National Institute on Drug Abuse (NIDA)
Principal Investigator: Joy Schmitz, PhD University of Texas
National Institute on Drug Abuse (NIDA)
December 2009

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