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Galantamine and CBT4CBT Pilot to Prevent Relapse.

Primary Purpose

Methadone or Buprenorphine Detoxoxification

Status

Completed

Phase

Early Phase 1

Locations

United States

Study Type

Interventional

Intervention

MAT taper with galantamine

MAT taper with placebo

About this trial

This is an interventional treatment trial for Methadone or Buprenorphine Detoxoxification

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Are male and females, between the ages of 18 and 65
Are enrolled in the APT methadone or buprenorphine program, have been stabilized for at least one year, and who voluntarily wish to taper off MAT.
For women of child-bearing age, have a negative serum pregnancy test at screening, agree to adequate contraception to prevent pregnancy, and agree to have monthly urine pregnancy tests at the clinic.
Are fluent in English and have a 6th grade or higher reading level.
Can commit to at least 12 weeks of treatment and are willing to be randomized to treatment

Exclusion Criteria:

Are undergoing administrative (non-voluntary) tapering (e.g., example due to non-payment of program fees, program rule infractions).
Meet DSM-V psychiatric classifications for lifetime schizophrenia or bipolar disorder, or have a depressive or anxiety disorder with current use of a prescribed psychotropic medication that cannot be discontinued;
Current DSM-V diagnosis of drug or alcohol use disorder (other than opioids or tobacco);
Demonstrate significant medical conditions, including asthma or chronic obstructive lung disease, history or current gastrointestinal ulcer, hepatic or renal impairment and cardiac rhythm disturbances or any other medical conditions that the study physician deems contraindicated for galantamine treatment;
Use of other medications including a) drugs that slow heart rate (e.g., beta-blockers),which may increase the risk of bradycardia and AV block and b) NSAIDs; increased potential for developing ulcers/active or occult gastrointestinal bleeding;
Have a screening liver function test (AST or ALT) greater than 3 times normal;
Known allergy or adverse reaction to galantamine

Sites / Locations

APT Foundation

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

MAT taper with galantamine

MAT taper with placebo

Arm Description

Following initial MAT taper, participants will be given up to 16mg daily of galantamine for up to 10 weeks of the active study

Following initial MAT taper, participants will be given up to 16mg daily of placebo for up to 10 weeks of the active study

Outcomes

Primary Outcome Measures

Change in Methadone/Buprenorphine Dose to 0 mg for Successful Completion of Taper

Number of participants who were able to taper to 0 mg from methadone or buprenorphine over 10 weeks of treatment. Data about current medication and dose in mg was collected at the start of treatment (week 1) was recorded on a weekly medical sheet. Data was then collected weekly from participant self-report and verified through the clinic database.

Secondary Outcome Measures

Clinical Opioid Withdrawal Scale (COWS)

opioid withdrawal score at week 0 (baseline) and at 10 weeks (post treatment). 11-item scale designed to be administered by a clinician. Rates common signs and symptoms of opiate withdrawal and can be monitored over time. The summed score for the complete scale can be used to help clinicians determine the stage or severity of opiate withdrawal and assess the level of physical dependence on opioids. Score of 5-12 = mild; 13-24=moderate; 25-36=moderately severe; more than 36=severe withdrawal (Scale of 0 to 40).

Substance Use Calendar

number of days of opioid use, assessed by self-report

Full Information

NCT ID

NCT03547622

First Posted

March 15, 2018

Last Updated

July 27, 2022

Sponsor

Yale University

Collaborators

National Institute on Drug Abuse (NIDA)

1. Study Identification

Unique Protocol Identification Number

NCT03547622

Brief Title

Galantamine and CBT4CBT Pilot to Prevent Relapse.

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2022

Overall Recruitment Status

Completed

Study Start Date

May 1, 2018 (Actual)

Primary Completion Date

February 28, 2019 (Actual)

Study Completion Date

February 28, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Yale University

Collaborators

National Institute on Drug Abuse (NIDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

Detailed Description

This is a randomized pilot study to examine the potential use of galantamine as an adjunct to the standard buprenorphine or methadone taper in the context of behavioral support. Early abstinence from opioids is associated with high relapse rates and there is a great need to develop interventions that will prevent relapse to opioid use. In this randomized pilot, 30 adults enrolled in the methadone or buprenorphine maintenance programs at the APT Foundation and who have sought a medically supervised, voluntary taper from these medications will be offered participation in a double-blind, placebo controlled, randomized trial of galantamine as an adjunct to standard tapering procedures at this clinic along with the combined approach utilizing concurrent behavior therapy. Primary outcomes will be: (1) successful completion of taper (achieving a methadone/buprenorphine dose of 0), (2) opioid withdrawal symptoms, and (3) opioid use, assessed by self-report and urine samples during and up to 3 months after the end of opioid taper. The investigators will also closely monitor patient comfort and safety (assessed by opioid withdrawal symptoms, adverse events, with measures of stress, sleep and pain) as well as cognitive function (assessed by the CANTAB).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Methadone or Buprenorphine Detoxoxification

7. Study Design

Primary Purpose

Treatment

Study Phase

Early Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare Provider

Allocation

Randomized

Enrollment

6 (Actual)

8. Arms, Groups, and Interventions

Arm Title

MAT taper with galantamine

Arm Type

Active Comparator

Arm Description

Following initial MAT taper, participants will be given up to 16mg daily of galantamine for up to 10 weeks of the active study

Arm Title

MAT taper with placebo

Arm Type

Placebo Comparator

Arm Description

Following initial MAT taper, participants will be given up to 16mg daily of placebo for up to 10 weeks of the active study

Intervention Type

Drug

Intervention Name(s)

MAT taper with galantamine

Other Intervention Name(s)

Razadyne ER, Razadyne

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

MAT taper with placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in Methadone/Buprenorphine Dose to 0 mg for Successful Completion of Taper

Description

Time Frame

during 10 weeks of study and up to 3 months after the end of opioid taper

Secondary Outcome Measure Information:

Title

Clinical Opioid Withdrawal Scale (COWS)

Description

Time Frame

Data at week 0 (baseline) and week 10 (post treatment)

Title

Substance Use Calendar

Description

number of days of opioid use, assessed by self-report

Time Frame

during 10 weeks of study

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Are male and females, between the ages of 18 and 65 Are enrolled in the APT methadone or buprenorphine program, have been stabilized for at least one year, and who voluntarily wish to taper off MAT. For women of child-bearing age, have a negative serum pregnancy test at screening, agree to adequate contraception to prevent pregnancy, and agree to have monthly urine pregnancy tests at the clinic. Are fluent in English and have a 6th grade or higher reading level. Can commit to at least 12 weeks of treatment and are willing to be randomized to treatment Exclusion Criteria: Are undergoing administrative (non-voluntary) tapering (e.g., example due to non-payment of program fees, program rule infractions). Meet DSM-V psychiatric classifications for lifetime schizophrenia or bipolar disorder, or have a depressive or anxiety disorder with current use of a prescribed psychotropic medication that cannot be discontinued; Current DSM-V diagnosis of drug or alcohol use disorder (other than opioids or tobacco); Demonstrate significant medical conditions, including asthma or chronic obstructive lung disease, history or current gastrointestinal ulcer, hepatic or renal impairment and cardiac rhythm disturbances or any other medical conditions that the study physician deems contraindicated for galantamine treatment; Use of other medications including a) drugs that slow heart rate (e.g., beta-blockers),which may increase the risk of bradycardia and AV block and b) NSAIDs; increased potential for developing ulcers/active or occult gastrointestinal bleeding; Have a screening liver function test (AST or ALT) greater than 3 times normal; Known allergy or adverse reaction to galantamine

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kathleen M Carroll, PhD

Organizational Affiliation

Yale University

Official's Role

Principal Investigator

Facility Information:

Facility Name

APT Foundation

City

New Haven

State/Province

Connecticut

ZIP/Postal Code

06511

Country

United States

12. IPD Sharing Statement

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Galantamine and CBT4CBT Pilot to Prevent Relapse.

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