CI

At a glance

ClinicalIndex Comparison Record
Early Ph 1Completed· 6 enrolled
Drug / intervention
MAT taper with galantamine +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03547622
NCT03547622Early Ph 1Completed
CompareCT.gov

Pilot Study of Galantamine and CBT4CBT to Reduce Post-taper Relapse for MAT

Yale University·interventional·Posted Jun 6, 2018·Updated Aug 19, 2022

In Brief

A Early Phase 1 clinical trial evaluating MAT taper with galantamine and MAT taper with placebo for Methadone or Buprenorphine Detoxoxification. Completed, enrolled 6 participants across 1 site.

Detailed Summary

The investigators are proposing a randomized pilot feasibility study to evaluate the effects of galantamine versus placebo on preventing relapse to opioid use following tapering from methadone or buprenorphine maintenance (Medication Assisted Treatment, or MAT) among adults with opioid use disorder, with additional behavioral therapy (web-based cognitive behavioral therapy) provided across all conditions to help individuals successfully transition from MAT to a drug-free state.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMethadone or Buprenorphine Detoxoxification
CountriesUnited States
CollaboratorsNational Institute on Drug Abuse (NIDA)

Timeline

Early Ph 1CompletedFinished
20192020202120222023202420252026
First PostedJun 6, 2018
Enrollment StartMay 1, 2018
Primary CompletionFeb 28, 2019
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 8.1 years ago

Interventions

MAT taper with galantaminedrug

Following taper from MAT (methadone or buprenorphine) participants will be given galantamine daily with access to a CBT4CBT computer program

MAT taper with placebodrug

Following taper from MAT (methadone or buprenorphine) participants will be given placebo daily with access to a CBT4CBT computer program