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| Sponsor: | University of Arkansas |
|---|---|
| Collaborator: |
Yale University |
| Information provided by (Responsible Party): | University of Arkansas |
| ClinicalTrials.gov Identifier: | NCT00218608 |
Purpose
Cocaine is an extremely addictive stimulant drug that directly affects the brain. It is used in several different forms and can be snorted, smoked, or injected to achieve the desired effect. Cocaine users are at risk for many health problems, both directly and indirectly related to the effects of cocaine. Disulfiram, a drug used to treat chronic alcoholism, may be effective in reducing cocaine use. This study will evaluate the effectiveness of three different doses of disulfiram in treating cocaine dependence in opioid- and cocaine-dependent individuals maintained on methadone.
| Condition | Intervention | Phase |
|---|---|---|
|
Cocaine-Related Disorders Opioid-Related Disorders |
Drug: Disulfiram |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Disulfiram for Cocaine Abuse in Methadone- Patients |
| Enrollment: | 158 |
| Study Start Date: | April 2001 |
| Study Completion Date: | January 2007 |
| Primary Completion Date: | January 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: Placebo
Placebo (microcrystalline cellulose) was suspended in the methadone during weeks 3-14.
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Drug: Disulfiram
Disulfiram at 0, 62.5, 125 and 250 mg/day were administered during weeks 3-14
Other Name: Antabuse
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Active Comparator: Disulfiram at 62.5 mg
Disulfiram at 62.5 mg was suspended in the methadone during weeks 3-14.
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Drug: Disulfiram
Disulfiram at 0, 62.5, 125 and 250 mg/day were administered during weeks 3-14
Other Name: Antabuse
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Active Comparator: Disulfiram at 125 mg
Disulfiram at 125 mg/day was suspended in methadone during weeks 3-14.
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Drug: Disulfiram
Disulfiram at 0, 62.5, 125 and 250 mg/day were administered during weeks 3-14
Other Name: Antabuse
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Active Comparator: Disulfiram at 250 mg
Disulfiram at 250 mg/day was suspended in methadone during weeks 3-14.
|
Drug: Disulfiram
Disulfiram at 0, 62.5, 125 and 250 mg/day were administered during weeks 3-14
Other Name: Antabuse
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Despite the harm that cocaine can cause to the body, its abuse is widespread. It is the cause of more visits to hospital emergency rooms nationwide than any other illegal drug. Effective treatments for cocaine and opiate addictions are essential to the decline of cocaine- and opiate-related disorders. Unfortunately, cocaine use remains prevalent among participants in many opioid maintenance programs. The addition of other medications to methadone maintenance may prove helpful in reducing cocaine use. Disulfiram, a drug used to treat chronic alcoholism, causes unpleasant effects when even small amounts of alcohol are consumed. This study will evaluate the effectiveness of three different doses of disulfiram in treating cocaine dependence in opioid- and cocaine-dependent individuals maintained on methadone.
Participants in this double blind study will be randomly assigned to receive either disulfiram at one of three dosage levels (62.5, 125, 250 mg/day) or placebo for 14 weeks. During the first 2 weeks, doses of methadone plus either disulfiram or placebo will be administered until the assigned maintenance dose is achieved. This dosage level will be maintained for the duration of the study. Participants will be required to report to the study site Monday through Saturday of each week for assessments and to receive medication. They will receive a take-home dose of medication for Sunday. In addition, participants will receive a weekly session of cognitive-behavioral therapy. Urine samples will be collected three times a week to assess drug use. At the end of the study, participants will undergo a 4- to 6-week detoxification period in which they will gradually discontinue the use of methadone and disulfiram. All participants have the option to request transfer to a local methadone maintenance program instead of undergoing detoxification.
Enrollment has been completed and no subjects are active. Data analyses are being conducted at this time.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Arkansas | |
| University of Arkansas for Medical Sciences | |
| Little Rock, Arkansas, United States, 72205 7911 | |
| Principal Investigator: | Alison Oliveto, PhD | UAMS |
More Information
| Responsible Party: | University of Arkansas |
| ClinicalTrials.gov Identifier: | NCT00218608 History of Changes |
| Other Study ID Numbers: | NIDA-13441-1, R01-13441-1, DPMC |
| Study First Received: | September 20, 2005 |
| Last Updated: | January 26, 2012 |
| Health Authority: | United States: Federal Government |
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Cocaine Abuse |
|
Cocaine-Related Disorders Opioid-Related Disorders Substance-Related Disorders Mental Disorders Cocaine Disulfiram Methadone Vasoconstrictor Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions Dopamine Uptake Inhibitors Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |
Neurotransmitter Uptake Inhibitors Physiological Effects of Drugs Anesthetics, Local Anesthetics Central Nervous System Depressants Sensory System Agents Peripheral Nervous System Agents Central Nervous System Agents Enzyme Inhibitors Alcohol Deterrents Analgesics, Opioid Analgesics Antitussive Agents Respiratory System Agents Narcotics |
