Addition of Naltrexone to Methadone Taper

Status Completed

Clinical Trial Summary

There is a continuing search for more effective opiate detoxification treatments. This study's purpose is to investigate the effects of adding very low doses of naltrexone to a methadone tapering treatment in opioid dependent individuals.

Clinical Trial Description

Although many different techniques for opiate detoxification exist, the search continues for more effective approaches to reduce the duration and discomfort associated with opioid withdrawal. It has been shown that very low doses of naltrexone administered in the presence of opiates has analgesic and dependency reducing properties. The purpose of this study is to investigate the effects of very low doses of naltrexone administered during a methadone tapering schedule for opiate detoxification. In addition, this study will compare the effectiveness of two different dose regimens of naltrexone.

Participants in this double-blind study will be recruited among opioid dependent individuals already enrolled in a 6-day inpatient opioid detoxification program. Participants will be already receiving standard treatment to control discomfort during a methadone tapering schedule. Participants will be randomly assigned to one of three groups. Two of the groups will be given naltrexone; Group 1 will receive 0.125 mg each day, and Group 2 will receive 0.250 mg each day. Group 3 will receive a placebo. Participants will be evaluated upon enrollment for opiate addiction severity. They will continue to be evaluated daily for signs of withdrawal and salivary cortisol. An additional evaluation and urine test will be completed 1 day following discharge. Daily evaluations will take 15 minutes to complete. Seven days following discharge, participants will be contacted for a 20-minute phone interview. During the phone interview, participants will schedule an appointment to provide a final urine specimen for the detection of drugs of abuse. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00135759
Study type	Interventional
Source	National Institute on Drug Abuse (NIDA)
Contact
Status	Completed
Phase	Phase 2
Start date	April 2005
Completion date	July 2006

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05054738` - CRP and S&A for Inpatient Veterans	N/A
Recruiting	`NCT04157062` - An Open-Label Trial of Repetitive Transcranial Magnetic Stimulation for Opioid Use Disorder	N/A
Completed	`NCT02233738` - Group Motivational Interviewing (GMI) For Homeless Veterans In VA Services	N/A
Enrolling by invitation	`NCT06084221` - Fatal Overdose Review Teams - Research to Enhance Surveillance Systems	N/A
Completed	`NCT02907944` - Working With HIV Clinics to Adopt Addiction Treatments Using Implementation Facilitation	N/A
Completed	`NCT02829970` - Helping College Students With ADHD Lead Healthier Lifestyles	N/A
Completed	`NCT02570360` - Exercise and Treatment-as-usual in Substance Use Treatment Outcomes	N/A
Completed	`NCT02945371` - Tailored Inhibitory Control Training to Reverse EA-linked Deficits in Mid-life	N/A
Completed	`NCT02388243` - The Computer-based Drug and Alcohol Training Assessment in Kenya	N/A
Completed	`NCT02715557` - Arise: An Online Relapse Prevention Tool for Adolescent Substance Abusers	N/A
Completed	`NCT02125539` - Field Trial of a Relapse Prevention Program for Adolescents Receiving Substance Use Treatment	Phase 2
Completed	`NCT02218970` - The Effect of Muscular Strength Training in Patients With Drug Addiction	N/A
Completed	`NCT01633138` - Performance-based Reinforcement to Enhance Cognitive Remediation Therapy	N/A
Completed	`NCT01591239` - Home-Based Program to Help Parents of Drug Abusing Adolescents	N/A
Active, not recruiting	`NCT01539525` - Screening to Augment Referral to Treatment- Project START	Phase 2
Withdrawn	`NCT01224002` - A Comparative Feasibility Study to Assess the Prevalence and Severity of Dental Caries in Incarcerated People Who Abuse Methamphetamine	N/A
Withdrawn	`NCT00891631` - Primary Care iSBIRT to Reduce Serious Teen Health Risks	Phase 1/Phase 2
Completed	`NCT00970372` - Dual-Diagnosis and Compulsory Treatment	N/A
Completed	`NCT01365247` - Concurrent Treatment for Substance Dependent Individuals With Post-Traumatic Stress Disorder (PTSD)	N/A
Completed	`NCT00419029` - Motivational Interviewing to Engage Operations Enduring Freedom and Iraqi Freedom (OEF/OIF) Veterans in Mental Health Treatment	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.