Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by:
National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
NCT00218530
First received: September 16, 2005
Last updated: November 21, 2005
Last verified: September 2005
  Purpose

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.


Condition Intervention Phase
Heroin Dependence
Drug: Lofexidine
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Naltrexone and Lofexidine in Detoxified Heroin Addicts

Resource links provided by NLM:


Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:
  • Retention in treatment; measured throughout 8 weeks
  • Frequency and amount of opiate use; measured weekly
  • Stress levels; measured weekly

Secondary Outcome Measures:
  • Tolerability; measured throughout 8 weeks

Estimated Enrollment: 0
Study Start Date: March 2003
Estimated Study Completion Date: September 2004
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 result of naltrexone's inability to reduce symptoms of stress during early recovery. 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 capabilities. The purpose of this study is to determine the maximal safe dose of lofexidine tolerated in naltrexone-treated opiate addicts and to find an optimal lofexidine induction schedule. The study will also assess any side effects that occur during a discontinuation phase of lofexidine.

This pilot study will last a total of 8 weeks. Recently detoxified opiate dependent participants who are eligible for naltrexone treatment will enter a 4-week single-blind dose tolerability phase, during which participants will receive naltrexone and 1 of 3 twice-daily lofexidine induction schedules. All participants will be required to remain in the clinic for 2 hours immediately following dosing in order to monitor vital signs and side effects. Study visits will occur three times each week, at which time naltrexone medication for self-administration will be handed out and participants will be evaluated in terms of tolerability to treatment. After the 4 weeks of treatment, a double-blind lofexidine detoxification phase using a 5-day taper will occur. Participants will be randomly assigned to one of two maintenance-taper schedules. The first group will undergo a 5-day tapering, followed by a placebo for three weeks, followed by a 5-day tapering during Week 4. Withdrawal symptoms and side effects will be evaluated.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00218530

Locations
United States, Connecticut
Substance Abuse Treatment Unit
New Haven, Connecticut, United States, 06511
Sponsors and Collaborators
Investigators
Principal Investigator: Thomas R Kosten, M.D. Yale University
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00218530     History of Changes
Other Study ID Numbers: NIDA-18197-1, P50-18197-1, DPMC
Study First Received: September 16, 2005
Last Updated: November 21, 2005
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Heroin Dependence
Chemically-Induced Disorders
Mental Disorders
Opioid-Related Disorders
Substance-Related Disorders
Lofexidine
Adrenergic Agents
Adrenergic Agonists
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Antihypertensive Agents
Cardiovascular Agents
Central Nervous System Agents
Molecular Mechanisms of Pharmacological Action
Narcotic Antagonists
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014