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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


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
See also
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Active, not recruiting NCT00094315 - Development of Human Laboratory Study Model of Cocaine Relapse Prevention II - 1 Phase 1
Terminated NCT00142883 - The Effects of GABA Enhancing Medications on Individuals Addicted to Cocaine - 3 N/A
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Completed NCT00158132 - Effectiveness of Amantadine and Propranolol for Treating Cocaine Dependence - 2 Phase 2
Completed NCT00142844 - Combination of Disulfiram Plus Naltrexone to Treat Both Cocaine- and Alcohol-dependent Individuals - 1 Phase 2
Completed NCT00000294 - Effects of Carvedilol on Cocaine Use in Humans - 11 Phase 2
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Completed NCT00000277 - Mazindol for Cocaine Abuse - 2 Phase 2
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Completed NCT00000280 - Glutaminergic Agents for Cocaine Abuse - 5 Phase 1
Terminated NCT00000276 - Dopamine Reuptake Inhibitors of Cocaine Abuse - 1 Phase 1
Completed NCT00000282 - Pemoline for Cocaine Abuse - 7 Phase 2
Completed NCT00000306 - Dextroamphetamine as Adjunct in Cocaine/Opiate Dependent Patients - 3 Phase 2
Completed NCT00000188 - Selegiline in Treatment of Cocaine Dependence - 2 Phase 2