Surmounting Withdrawal to Initiate Fast Treatment With Naltrexone

NACompletedINTERVENTIONAL
Enrollment

415

Participants

Timeline

Start Date

March 16, 2021

Primary Completion Date

July 19, 2022

Study Completion Date

December 21, 2022

Conditions
Opioid-use Disorder
Interventions
OTHER

Standard Induction Procedure (SP)

SP includes stabilization on buprenorphine (6-8 mg) on Day 1 followed by a taper over the subsequent 4 days. After the completion of buprenorphine taper, participants will enter a washout period of at least 8 days. On the last day of the washout period, participants will be evaluated for eligibility to receive XR-NTX injection. Once found eligible, an XR-NTX injection will be given.

OTHER

Rapid Induction Procedure (RP)

RP includes 1 day of buprenorphine 6-8 mg, followed by a day of washout and 4 days of oral naltrexone titration. If the participant is able to tolerate the last dose of the naltrexone titration, an XR-NTX injection will be given

Trial Locations (6)

11944

Stony Brook Eastern Long Island Hospital, Greenport

20853

Avery Road Treatment Center, Rockville

32810

Aspire Health Partners, Orlando

63703

Gibson Recovery Center, Inc., Cape Girardeau

75228

Nexus Recovery Center, Inc., Dallas

97470

Adapt, Roseburg

All Listed Sponsors
collaborator

National Institute on Drug Abuse (NIDA)

NIH

collaborator

The Emmes Company, LLC

INDUSTRY

lead

New York State Psychiatric Institute

OTHER

NCT04762537 - Surmounting Withdrawal to Initiate Fast Treatment With Naltrexone | Biotech Hunter | Biotech Hunter