Heroin Dependence Clinical Trial
Official title:
Naltrexone and Lofexidine in Detoxified Heroin Addicts
Stress is one of the more common reasons cited by addicts for continual drug use and relapse. Treatment approaches that target both drug-induced and stress-induced relapse may prove to be more beneficial than targeting drug-induced relapse alone. Lofexidine is a drug that reduces the physical symptoms of opiate withdrawal and may prove to have stress-reducing capabilites in drug addicts. The purpose of this study is to determine the maximal safe dose of lofexidine tolerated in naltrexone-treated heroin addicts and to find an optimal lofexidine induction schedule.
Status | Completed |
Enrollment | 0 |
Est. completion date | September 2004 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility |
Inclusion Criteria: - Meets DSM-IV criteria for opiate dependence - Use of heroin at least 3 times per week during the 3 months prior to entering opiate detoxification - Documented positive urine toxicology test for opiates - Successful initiation on naltrexone treatment as indicated by stabilization on 50 mg of naltrexone once a day - Reads English Exclusion Criteria: - Regular use of anticonvulsants, sedatives/hypnotics, prescription analgesics, antihypertensives (including clonidine), antirythmics, antiretroviral medications, and tricyclic antidepressants - Psychotic or otherwise severely psychiatrically disabled (e.g., suidical, homicidal, currently manic) - Abstinent from opiates for more than four weeks prior to naltrexone initiation - Any medical problems that might make naltrexone treatment unsafe, such as hepato-cellular injury as evidenced by abnormal liver enzyme tests (including SGOT, SGPT, and GGT levels greater than three times normal) and a history of cirrhosis - Hypotension with a resting blood pressure below 90/50 mm Hg - Pregnant, breastfeeding, or refusal to use a reliable form of contraception throughout the study |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Substance Abuse Treatment Unit | New Haven | Connecticut |
Lead Sponsor | Collaborator |
---|---|
National Institute on Drug Abuse (NIDA) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Retention in treatment; measured throughout 8 weeks | |||
Primary | Frequency and amount of opiate use; measured weekly | |||
Primary | Stress levels; measured weekly | |||
Secondary | Tolerability; measured throughout 8 weeks |
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