NCT02696434 is a Phase 3 clinical trial of Naltrexone in Opioid Use Disorder, sponsored by Alkermes, Inc..

Who is sponsoring NCT02696434?

NCT02696434 is sponsored by Alkermes, Inc..

What drugs are being tested in NCT02696434?

Interventions in NCT02696434: Naltrexone, Placebo, Buprenorphine.

What condition does NCT02696434 study?

NCT02696434 studies Opioid Use Disorder.

Is NCT02696434 still recruiting?

NCT02696434 is currently completed. Last updated 18 January 2019.

Are results published for NCT02696434?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2019-01-18 · How we verify

NCT02696434

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Safety, Tolerability, and Efficacy of Naltrexone for Use in Conjunction With Buprenorphine in Adults With Opioid Use Disorder Transitioning From Buprenorphine Maintenance Prior to First Dose of VIVITROL

Completed Phase 3 Results posted Last updated 18 January 2019

What this trial tests

Phase 3 trial testing Naltrexone in Opioid Use Disorder in 101 participants. Completed in 30 November 2017.

Timeline

1 April 2016

Primary endpoint
1 November 2017

30 November 2017

Quick facts

Lead sponsor	Alkermes, Inc.
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	101
Start date	1 April 2016
Primary completion	1 November 2017
Estimated completion	30 November 2017
Sites	9 locations across United States

Drugs / interventions tested

Naltrexone — full drug profile →
Placebo
Buprenorphine (BUPRENORPHINE) — full drug profile →

Conditions studied

Opioid Use Disorder — all drugs for Opioid Use Disorder →

Sponsor

Alkermes, Inc. — full company profile →

Who can join

Adults 18 to 60, any sex, with Opioid Use Disorder. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Proportion of Subjects Who Receive and Tolerate a VIVITROL Injection on Day 8
Time frame: 8 days
Demonstrated by mild opioid withdrawal symptoms (Clinical Opiate Withdrawal Scale \[COWS\] \</=12 or Subjective Opiate Withdrawal Scale \[SOWS\] \</=10) following VIVITROL administration. The COWS is a clinician-rated questionnaire designed to measure 11 common opioid withdrawal signs or symptoms. The summed score provides information about the level of physical dependence on opioids. The range of

Sponsor's own description

This study will evaluate the efficacy, safety, and tolerability of oral naltrexone used in conjunction with buprenorphine in adults with Opioid Use Disorder transitioning from buprenorphine maintenance prior to the first dose of VIVITROL.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

Transition of Patients with Opioid Use Disorder from Buprenorphine to Extended-Release Naltrexone: A Randomized Clinical Trial Assessing Two Transition Regimens.
Comer SD, Mannelli P, Alam D, Douaihy A, et al · · 2020 · cited 6× · PMID 32246728 · DOI 10.1111/ajad.13024
Characteristics and treatment preferences of individuals with opioid use disorder seeking to transition from buprenorphine to extended-release naltrexone in a residential setting.
Mannelli P, Douaihy AB, Akerman SC, Legedza A, et al · · 2022 · cited 3× · PMID 35137481 · DOI 10.1111/ajad.13264
Sustained-release naltrexone for opioid dependence.
Kornør H, Lobmaier PPK, Kunøe N. · · 2025 · cited 2× · PMID 40342086 · DOI 10.1002/14651858.cd006140.pub3
Patterns of withdrawal in patients with opioid use disorder (OUD) transitioning from untreated OUD or buprenorphine treatment to extended-release naltrexone.
Mannelli P, Douaihy AB, Zavod A, Legedza A, et al · · 2021 · cited 1× · PMID 34752714 · DOI 10.1080/00952990.2021.1969659

Verify or expand the search:

Other trials of Naltrexone

Trials testing the same drug.

NCT07433413 — Evaluate the Efficacy and Safety of Naltrexone Hydrochloride Implant in Patients With Alcohol Use Disorder · Phase 3 · not yet recruiting
NCT06622239 — Trial to Evaluate the Effects of Naltrexone in Nonsuicidal Self-injury · Phase 2 · not yet recruiting
NCT06426303 — Sex Differences in Trauma, Inflammation and Brain Function and the Implications for Treatment Efficacy in Alcohol Use Di · Phase 4 · recruiting
NCT05968690 — Naltrexone and Propranolol Combined With Immunotherapy · Phase 1 · recruiting
NCT05458609 — Lemborexant Augmentation of Naltrexone for Alcohol Craving and Sleep · Phase 3 · completed

Other recruiting trials for Opioid Use Disorder

Currently open trials in the same condition.

NCT07278518 — Evaluation of a Patient Decision Aid for Emergency Department Initiated Buprenorphine · NA · recruiting
NCT07044466 — Social Functioning in Opioid Use Disorder · NA · recruiting
NCT07158853 — Combined tDCS and Cognitive Training as an Adjunctive Treatment in Opioid Use Disorder · NA · recruiting
NCT06943859 — Ketamine for Opioid Use Disorder · Phase 2 · recruiting
NCT06651177 — Evaluation of Tirzepatide as an Adjunct to Buprenorphine for the Treatment of Opioid Use Disorder · Phase 2 · recruiting

Other Alkermes, Inc. trials

Trials by the same sponsor.

NCT06555783 — A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects With Narcolepsy Type 2 · Phase 2 · completed
NCT06358950 — A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects With Narcolepsy Type 1 (ALKS 2680-201) · Phase 2 · completed
NCT05547100 — Study of the Breast Milk Pharmacokinetics of Olanzapine and Samidorphan · Phase 1 · completed
NCT05019105 — Phase 1 ALKS 1140 in Healthy Adults · Phase 1 · terminated
NCT04987658 — Phase 1 Study of OLZ/SAM in Pediatric Subjects With Bipolar I Disorder · Phase 1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02696434 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Alkermes, Inc.
Last refreshed: 18 January 2019

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02696434.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing