Medications for Stopping Cocaine Dependence and Preventing Relapse
Recruitment status was Recruiting
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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 |
- 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 |
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| 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, 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 | |
| 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 Substance-Related Disorders Mental Disorders Carbidopa Levodopa Naltrexone Modafinil Antiparkinson Agents Anti-Dyskinesia Agents Central Nervous System Agents Therapeutic Uses Pharmacologic Actions |
Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Dopamine Agents Neurotransmitter Agents Physiological Effects of Drugs Narcotic Antagonists Sensory System Agents Peripheral Nervous System Agents Central Nervous System Stimulants Neuroprotective Agents Protective Agents |
ClinicalTrials.gov processed this record on May 16, 2013