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NCT01377610 · ClinicalTrials.gov registry record · Phase 1
Improved Strategies for Outpatient Opioid Detoxification
A Phase 1 study of Opioid Dependence, sponsored by New York State Psychiatric Institute.
- Completed
- Registry status
- Phase 1
- Development phase
- 150
- Enrollment target
- 1
- Study location
NCT01377610 is a Phase 1 study of Opioid Dependence that has completed, run by New York State Psychiatric Institute. The registered enrollment target is 150 participants, roughly in line with the 153-participant average among 29 other Opioid Dependence trials with a reported enrollment target. The trial reports 1 study location across 1 state.
The verdict
NCT01377610, a Phase 1 study of Opioid Dependence, has completed, sponsored by New York State Psychiatric Institute.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 150 participants
- Enrollment target
- 1
- Study location
Study Summary
The investigators will randomize 210 opioid-dependent participants to one of two outpatient detoxification strategies: (1) a standard 7-day buprenorphine induction and gradual taper from 8 mg to 0 mg vs. (2) 7-day oral naltrexone induction; both groups will receive a single administration of a Vivitrol injection: at Day 8 for the naltrexone induction group and Day 15 for the buprenorphine group. The naltrexone arm is a modification of our current inpatient naltrexone induction procedure, consisting of a single day of buprenorphine followed by a washout day and 4 days of ascending oral naltrexone doses, prior to administering a dose of injectable naltrexone on Day 8. All participants will receive an intensive behavioral therapy for five weeks and will be followed for the subsequent 8 weeks to assess the longer-term outcome of the initial treatment. The primary outcome will be percentage of patients in each group successfully inducted onto Vivitrol. Key secondary outcomes will be 2-week abstinence at Weeks 4-5 (3rd and 4th weeks after Vivitrol injection), rates of completion of the 8-day detoxification, and percentage of patients in each group who return for additional Vivitrol injections in post-study follow-up. The main goal of this Stage 1a pilot study is to develop an improved outpatient opioid detoxification strategy, with particular relevance to newly diagnosed heroin addicts and prescription opioid abusers not seeking long-term agonist maintenance. Specific Aim #1: To develop procedures for outpatient opioid detoxification which include naltrexone to facilitate detoxification. Specific Aim #2: To compare injectable naltrexone induction rates between the naltrexone and buprenorphine groups following short-term outpatient opioid detoxification approach for initiating treatment for opioid dependence.
Conditions Studied
Interventions
- DRUG Buprenorphine
- DRUG oral naltrexone
- DRUG Vivitrol
Study Locations (1)
New York
- Substance Treatment and Research Service (STARS), Columbia University - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2011-06 |
| Est. Completion | 2017-12 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01377610
The ClinicalTrials.gov registry entry for NCT01377610 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 153-participant average among 29 other Opioid Dependence trials with a reported enrollment target. The listed sponsor is New York State Psychiatric Institute, which has 364 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Opioid Dependence appearing as the primary indexed condition, and to 3 interventions - of which Buprenorphine is the first listed.
NCT01377610 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.
Frequently Asked Questions
What is clinical trial NCT01377610 about?
NCT01377610 is a clinical study titled "Improved Strategies for Outpatient Opioid Detoxification". The investigators will randomize 210 opioid-dependent participants to one of two outpatient detoxification strategies: (1) a standard 7-day buprenorphine induction and gradual taper from 8 mg to 0 mg vs. (2) 7-day oral naltrexone induction; both groups will receive a single administration of a Vivit...
What is the current status of trial NCT01377610?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 150 participants. The study started on 2011-06. Estimated completion is 2017-12.
What conditions does trial NCT01377610 study?
This clinical trial studies the following conditions: Opioid Dependence.
What interventions are being tested in trial NCT01377610?
The interventions under investigation include: Buprenorphine (DRUG), oral naltrexone (DRUG), Vivitrol (DRUG).
Who is sponsoring clinical trial NCT01377610?
This trial is sponsored by New York State Psychiatric Institute, which has 364 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01377610 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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