Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00135759
Status:
COMPLETED
Last Update Posted:
2017-01-12
First Post:
2005-08-23
Brief Title:
Addition of Naltrexone to Methadone Taper
Sponsor:
National Institute on Drug Abuse NIDA
Organization:
National Institute on Drug Abuse NIDA
Study Overview
Official Title:
Place of Low-Dose Naltrexone in Opiate Detoxification
Status:
COMPLETED
Status Verified Date:
2008-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
There is a continuing search for more effective opiate detoxification treatments This studys purpose is to investigate the effects of adding very low doses of naltrexone to a methadone tapering treatment in opioid dependent individuals
Detailed 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 0125 mg each day and Group 2 will receive 0250 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
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 0125 mg each day and Group 2 will receive 0250 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| DPMC | None | None | None |
| R21-15469-1 | None | None | None |