Effectiveness of Naltrexone and Lofexidine in Treating Detoxified Heroin Addicts - 1

• Status: Completed
• Trial end date: 2004-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute on Drug Abuse (NIDA)
• Treatments: Clonidine; Heroin; Lofexidine; Naltrexone

Criteria

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