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

NCT00218530 | Completed Phase 1

• 3 other identifiers: NIDA-18197-1P50-18197-1DPMC
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Heroin Dependence

Outcome Measures

Primary Outcomes (3)

• Retention in treatment; measured throughout 8 weeks

• Frequency and amount of opiate use; measured weekly

• Stress levels; measured weekly

Secondary Outcomes (1)

• Tolerability; measured throughout 8 weeks

Interventions

Lofexidine DRUG

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• National Institute on Drug Abuse (NIDA): lead

Study Sites (1)

Substance Abuse Treatment Unit

New Haven, Connecticut, 06511, United States

Location

MeSH Terms

Conditions

Heroin Dependence

Interventions

lofexidine

Condition Hierarchy (Ancestors)

Opioid-Related Disorders; Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Thomas R Kosten, M.D.

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH

Study Record Dates

• First Submitted: September 16, 2005
• First Posted: September 22, 2005
• Study Start: March 1, 2003
• Study Completion: September 1, 2004
• Last Updated: January 12, 2017

Record last verified: 2016-10

Locations

US (1)