Effectiveness of Naltrexone and Lofexidine in Treating Detoxified Heroin Addicts - 1
Completed · Phase 1
Conditions studied: Heroin Dependence
In brief
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.
Key facts
- Study ID
- NCT00218530
- Run by
- National Institute on Drug Abuse (NIDA)
- People needed
- 0
- Starts
- 2003-03-01
- Expected to finish
- 2004-09-01
- Last updated by the study team
- 2017-01-12
Who can join
Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Substance Abuse Treatment Unit — New Haven, Connecticut, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.