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NCT01733693 · ClinicalTrials.gov registry record · Phase 4
Neurocognitive Effects of Opiate Agonist Treatment
A Phase 4 study, sponsored by Albert Einstein College of Medicine.
- Completed
- Registry status
- Phase 4
- Development phase
- 135
- Enrollment target
NCT01733693: Completed Phase 4 study, sponsored by Albert Einstein College of Medicine.
NCT01733693 is a Phase 4 study that has completed, run by Albert Einstein College of Medicine. The registered enrollment target is 135 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (74% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01733693, a Phase 4 study, has completed, sponsored by Albert Einstein College of Medicine.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 135 participants
- Enrollment target
Study Summary
The purpose of this study is to (1) compare the effects of buprenorphine and methadone, two types of opioid addiction treatment, on the ability to think and reason among people addicted to opiates, and who are either HIV negative or HIV positive; and (2) investigate whether HIV infection changes the way opioid treatment affects the ability to think and reason. The investigators hypothesize that there will be (1) significant improvement in thinking and reasoning ability after starting buprenorphine treatment compared to methadone treatment, among participants with and without HIV at 2 and 4 months compared to baseline; and (2) HIV positive participants will demonstrate significant improvement in thinking and reasoning ability at 2 and 4 months compared to baseline, but that their thinking and reasoning ability will still be lower than HIV negative participants.
Primary Outcome
Metrics: A Global Deficit Score (GDS) is computed by adding deficit ratings of the component test measures, and dividing by total number of measures. (Please see list of component test measures under the Domain-Specific Neurocognitive Function outcome).
Interventions
- DRUG Methadone
- DRUG Buprenorphine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 135 participants |
| Start Date | 2013-01 |
| Est. Completion | 2017-06 |
| Phase | Phase 4 |
What the finished NCT01733693 record still lists
NCT01733693 is an interventional study that assigns participants to a tested intervention. The registered 135 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 (74% lower).
The record links to 0 conditions, and to 2 interventions - of which Methadone is the first listed.
NCT01733693 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01733693 about?
NCT01733693 is a clinical study titled "Neurocognitive Effects of Opiate Agonist Treatment". The purpose of this study is to (1) compare the effects of buprenorphine and methadone, two types of opioid addiction treatment, on the ability to think and reason among people addicted to opiates, and who are either HIV negative or HIV positive; and (2) investigate whether HIV infection changes the...
What is the current status of trial NCT01733693?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 135 participants. The study started on 2013-01. Estimated completion is 2017-06.
What interventions are being tested in trial NCT01733693?
The interventions under investigation include: Methadone (DRUG), Buprenorphine (DRUG).
Who is sponsoring clinical trial NCT01733693?
This trial is sponsored by Albert Einstein College of Medicine, which has 175 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01733693's enrollment target sits among peer trials
135 601st of 2000 higher than 1,395 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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