Addition of Naltrexone to Methadone Taper
| Status: | Completed |
|---|---|
| Conditions: | Psychiatric, Psychiatric, Gastrointestinal |
| Therapuetic Areas: | Gastroenterology, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 1/13/2017 |
| Start Date: | April 2005 |
| End Date: | July 2006 |
Place of Low-Dose Naltrexone in Opiate Detoxification
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.
study's purpose is to investigate the effects of adding very low doses of naltrexone to a
methadone tapering treatment in opioid dependent individuals.
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.
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.
Inclusion Criteria:
- Current DSM-IV diagnosis of opiate dependence
- Reads and understands English
Exclusion Criteria:
- Serious medical disorders (e.g., uncontrolled hypertension, acute or chronic active
hepatitis, kidney failure, uncontrolled diabetes)
- Psychiatric conditions that require intensive services (e.g., depression with
suicidal ideation, psychosis)
- Mental retardation or other disorder that might limit ability to give informed
consent
- Pregnant
We found this trial at
1
site
Duke University Younger than most other prestigious U.S. research universities, Duke University consistently ranks among...
Click here to add this to my saved trials
