Medications for Stopping Cocaine Dependence and Preventing Relapse

Cocaine-Related Disorders Clinical Trial

Official title:

Screening Medications for Cocaine Cessation and Relapse Prevention

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00218023
• Other study ID #: NIDA-09262-7
• Secondary ID: P50DA009262-07DP
• Status: Recruiting
• Phase: Phase 2
• First received: September 16, 2005
• Last updated: December 11, 2009
• Start date: March 2006
• Est. completion date: March 2011

Study information

• Verified date: December 2009
• Source: National Institute on Drug Abuse (NIDA)
• Contact: Laura B Madden-Fuentes, B.A.
• Phone: 713-500-2563
• Email: Laura.MaddenFuentes[@]uth.tmc.edu
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: March 2011
• Est. primary completion date: March 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cocaine Abuse
• Cocaine-Related Disorders

Intervention

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.
• 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.
• 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
• Placebo
Placebo

Locations

Country	Name	City	State
United States	University of Texas Health Science Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
University of Texas	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Confirmed abstinence from cocaine		12 weeks of treatment	No

External Links

•   Click here for more information about the University of Texas Treatment Research Clinic