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
  Purpose

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.


Condition Intervention Phase
Cocaine Abuse
Cocaine-Related Disorders
Drug: Naltrexone
Drug: Modafinil
Drug: Levodopa/Carbidopa
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Screening Medications for Cocaine Cessation and Relapse Prevention

Resource links provided by NLM:


Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:
  • Confirmed abstinence from cocaine [ Time Frame: 12 weeks of treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: March 2006
Estimated Study Completion Date: March 2011
Estimated Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Naltrexone hydrochloride , 50mg per day
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
Experimental: 2
Levodopa/carbidopa, 800/200 mg per day
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
Experimental: 3
Modafinil 200mg
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
Placebo Comparator: 4 Drug: Placebo
Placebo
Other Name: Placebo

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00218023

Contacts
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

Locations
United States, Texas
University of Texas Health Science Center Recruiting
Houston, Texas, United States, 77030
Contact: Ann Garcia, MA    713-500-2804    Ann.D.Garcia@uth.tmc.edu   
Sponsors and Collaborators
University of Texas
Investigators
Principal Investigator: Joy Schmitz, PhD University of Texas
  More Information

No publications provided

Responsible Party: Joy Schmitz, Ph.D., University of Texas Medical School at Houston
ClinicalTrials.gov Identifier: NCT00218023     History of Changes
Other Study ID Numbers: NIDA-09262-7, P50DA009262-07, DPMC
Study First Received: September 16, 2005
Last Updated: December 11, 2009
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Cocaine-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Substance-Related Disorders
Armodafinil
Carbidopa
Levodopa
Modafinil
Naltrexone
Anti-Dyskinesia Agents
Antiparkinson Agents
Central Nervous System Agents
Central Nervous System Stimulants
Dopamine Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Narcotic Antagonists
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses
Wakefulness-Promoting Agents

ClinicalTrials.gov processed this record on October 23, 2014