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NCT01893827 · ClinicalTrials.gov registry record · Phase 4
Extended-Release vs. Oral Naltrexone Alcohol Treatment in Primary Care
A Phase 4 study, sponsored by NYU Langone Health.
- Completed
- Registry status
- Phase 4
- Development phase
- 237
- Enrollment target
NCT01893827: Completed Phase 4 study, sponsored by NYU Langone Health.
NCT01893827 is a Phase 4 study that has completed, run by NYU Langone Health. The registered enrollment target is 237 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (54% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01893827, a Phase 4 study, has completed, sponsored by NYU Langone Health.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 237 participants
- Enrollment target
Study Summary
The proposed study is a pragmatic, randomized, open-label clinical trial of 24 weeks of XR-NTX vs. O-NTX using a COMBINE-adapted Medical Management primary care treatment model. 237 adults \>18yo with alcohol dependence will be recruited from the community into treatment in public sector primary care settings. The primary outcome which powers this study is a dichotomous good clinical outcome defined by abstinence or moderate drinking, and as measured by the Timeline Follow-back and analyzed using an intention-to-treat approach among all randomized participants. Secondary outcomes include the incremental cost effectiveness of the two arms, differences between arms by continuous measures of alcohol intake (drinks/day, % days abstinent, time to first heavy drinking day, bio-markers), and the exploratory analysis of factors possibly associated with effectiveness, including gender, prior treatment abstinence, and mu opioid receptor (OPRM1) genotypes. Specific Aim 1: Treatment Effectiveness. To evaluate the effectiveness of extended-release naltrexone (XR-NTX) vs. oral naltrexone (O-NTX) in producing a primary good clinical outcome, defined as abstinence or moderate drinking (≤2 drinks/day, men; ≤1 drink/day,women; and ≤2 heavy drinking occasions/month), during the final 20 of 24 weeks of primary care-based Medical Management for alcohol dependence. Hypothesis: The rate of this good clinical outcome will be approximately twice as great among participants receiving XR-NTX compared with those receiving O-NTX. Specific Aim 2: Cost Effectiveness. To estimate the incremental cost effectiveness of XR-NTX vs. O-NTX,both in conjunction with primary care-based Medical Management. Hypothesis: XR-NTX treatment will be more cost effective than O-NTX. Specific Aim 3: Patient-Level Predictors of Effectiveness. To identify patient-level characteristics associated with effectiveness in both arms.
Primary Outcome
Percentage of participants who had the following number of drinks (≤2 drinks/day, men; ≤1 drink/day, women; and ≤2 heavy drinking occasions/month) during the final 20 of 24 weeks of primary care-based Medical Management for alcohol dependence.
Interventions
- DRUG XR-NTX (Extended-Release Naltrexone)
- DRUG Oral Naltrexone (O-NTX)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 237 participants |
| Start Date | 2014-06 |
| Est. Completion | 2018-10-03 |
| Phase | Phase 4 |
What the finished NCT01893827 record still lists
NCT01893827 is an interventional study that assigns participants to a tested intervention. The registered 237 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (54% lower).
The record links to 0 conditions, and to 2 interventions - of which XR-NTX (Extended-Release Naltrexone) is the first listed.
NCT01893827 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01893827 about?
NCT01893827 is a clinical study titled "Extended-Release vs. Oral Naltrexone Alcohol Treatment in Primary Care". The proposed study is a pragmatic, randomized, open-label clinical trial of 24 weeks of XR-NTX vs. O-NTX using a COMBINE-adapted Medical Management primary care treatment model. 237 adults \>18yo with alcohol dependence will be recruited from the community into treatment in public sector primary car...
What is the current status of trial NCT01893827?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 237 participants. The study started on 2014-06. Estimated completion is 2018-10-03.
What interventions are being tested in trial NCT01893827?
The interventions under investigation include: XR-NTX (Extended-Release Naltrexone) (DRUG), Oral Naltrexone (O-NTX) (DRUG).
Who is sponsoring clinical trial NCT01893827?
This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01893827's enrollment target sits among peer trials
237 367th of 2000 higher than 1,634 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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