Duke University
Durham, North Carolina, 27704, United States
NCT Number: NCT00135759
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.
Looking for future studies?
Notify Me18 year–65 year
All sexes
Interventional
Phase 2
Durham, North Carolina, 27704, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
low dose naltrexone in addition to daily methadone taper
1 capsule/day for 6 days
Time frame: 6 days
Time frame: 6 days
National Institute on Drug Abuse (NIDA)
Nih
Place of Low-Dose Naltrexone in Opiate Detoxification
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT00000273
Chemically-Induced Disorders, Heroin Dependence
New York, United States
View Trial DetailsNCT00249470
Chemically-Induced Disorders, Cocaine-Related Disorders
Baltimore, Maryland, United States
View Trial DetailsNCT00015171
Chemically-Induced Disorders, Heroin Dependence
New York, United States
View Trial DetailsNCT00158288
Alcohol & Drug Use, Behavior Therapy
West Haven, Connecticut, United States
View Trial Details