Status:
COMPLETED
Effectiveness of Naltrexone and Lofexidine in Treating Detoxified Heroin Addicts - 1
Lead Sponsor:
National Institute on Drug Abuse (NIDA)
Conditions:
Heroin Dependence
Eligibility:
All Genders
18-100 years
Phase:
PHASE1
Brief 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 benefic...
Detailed Description
Stress is one of the more common reasons cited by addicts for continual drug use and relapse. Naltrexone treatment of opiate addicts suffers from high rates of drop-out and relapse. This may be a resu...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2003
Trial Type :
INTERVENTIONAL
End Date :
September 1 2004
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00218530
Start Date
March 1 2003
End Date
September 1 2004
Last Update
January 12 2017
Active Locations (1)
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1
Substance Abuse Treatment Unit
New Haven, Connecticut, United States, 06511