Trials / Active Not Recruiting
Active Not RecruitingNCT03345173
Facilitating Rapid Naltrexone Initiation
Glutamatergic Modulation to Facilitate Naltrexone Initiation: A Randomized, Controlled Trial
- Status
- Active Not Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- Sponsor
- New York State Psychiatric Institute · Academic / Other
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Accepted
Summary
The incidence of opioid use disorders (OUDs) has increased to near-epidemic proportions. While maintenance with long-acting opioids such as methadone or buprenorphine represents an effective treatment strategy, it may be unacceptable to many individuals. As a result, long-acting injectable naltrexone (XR-NTX), an antagonist medication that blocks the effects of opioids for at least 4 weeks, is now indicated for relapse prevention following detoxification. This randomized, controlled trial aims to test the efficacy of a glutamate modulator at facilitating a rapid non-opioid based naltrexone induction.
Detailed description
This study combines a nonopioid detoxification; a naltrexone titration schedule that allows for pushing the dose rapidly while monitoring closely to ensure tolerability; and infusions integrated into the treatment in such a way as to potentially ameliorate spontaneous and precipitated withdrawal. The first part of the treatment trial involves receiving inpatient treatment for up to 5 days. Following week 1, participants will meet with staff twice weekly and receive 12 weeks of mindfulness based relapse prevention and motivational interviewing sessions.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | CI-581-a | Two infusions in the context of naltrexone induction protocol. |
| DRUG | CI-581-b | Two infusions in the context of naltrexone induction protocol. |
Timeline
- Start date
- 2017-11-25
- Primary completion
- 2024-10-01
- Completion
- 2024-10-01
- First posted
- 2017-11-17
- Last updated
- 2024-02-02
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03345173. Inclusion in this directory is not an endorsement.