Methadone or Buprenorphine DetoxoxificationEarly Phase 1NCT03547622

Galantamine and CBT4CBT Pilot to Prevent Relapse.

A Early Phase 1 study testing MAT taper with galantamine in people with Methadone or Buprenorphine Detoxoxification, run by Yale University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Methadone or Buprenorphine Detoxoxification
What is being tested?: MAT taper with galantamine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 6 participants
Where: 1 siteUnited States
Study dates: 1 May 2018to 28 Feb 2019
Phase: Early Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

APT Foundation
New Haven, Connecticut, 06511

Other trials in United States

About this study

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

Read the 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).

Conditions: Methadone or Buprenorphine Detoxoxification
Being tested: MAT taper with galantamine, MAT taper with placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MAT taper with galantamineDrug
Also called Razadyne ER, Razadyne
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

Study groups in NCT03547622
Study group	Role	What they receive
MAT taper with galantamine	Active comparator	Following initial MAT taper, participants will be given up to 16mg daily of galantamine for up to 10 weeks of the active study Receives: Drug: MAT taper with galantamine
MAT taper with placebo	Placebo comparator	Following initial MAT taper, participants will be given up to 16mg daily of placebo for up to 10 weeks of the active study Receives: Drug: MAT taper with placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (2)

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).
Measured: Data at week 0 (baseline) and week 10 (post treatment)
Substance Use Calendar
number of days of opioid use, assessed by self-report
Measured: during 10 weeks of study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 May 201828 Feb 2019

First posted6 Jun 2018
Study start1 May 2018
Primary completion28 Feb 2019
Study completion28 Feb 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Methadone or Buprenorphine DetoxoxificationStudies of the same condition, open and under way.
More trials run by Yale UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Early Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Care provider
Enrolment: 6 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03547622
Sponsor's protocol ID: 2000021868
Other IDs: 2P50DA009241-21
Status last verified: Jul 2022
First submitted: 15 Mar 2018
Last updated: 19 Aug 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

Study at a glance

From the registry record, last updated by the sponsor on 19 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pilot Study of Galantamine and CBT4CBT to Reduce Post-taper Relapse for MAT
ClinicalTrials.gov ID: NCT03547622
Acronym / sponsor ID: 2000021868
Conditions: Methadone or Buprenorphine Detoxoxification
Phase: Early Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 6 participants (actual)
Lead sponsor: Yale UniversityUniversity, hospital or other
Collaborators: National Institute on Drug Abuse (NIDA)
Study start: 1 May 2018 (actual)
Primary completion: 28 Feb 2019 (actual)
Study completion: 28 Feb 2019 (actual)
First posted: 6 Jun 2018 (actual)
Results: Posted 19 Aug 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, care provider)
Number of arms: 2

Arm	Type	Receives
MAT taper with galantamine	Active comparator	Drug: MAT taper with galantamineFollowing initial MAT taper, participants will be given up to 16mg daily of galantamine for up to 10 weeks of the active study
MAT taper with placebo	Placebo comparator	Drug: MAT taper with placeboFollowing initial MAT taper, participants will be given up to 16mg daily of placebo for up to 10 weeks of the active study

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (7 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
MAT taper with galantamineAlso: Razadyne ER, RazadyneFollowing taper from MAT (methadone or buprenorphine) participants will be given galantamine daily with access to a CBT4CBT computer program	Drug	MAT taper with galantamine
MAT taper with placeboFollowing taper from MAT (methadone or buprenorphine) participants will be given placebo daily with access to a CBT4CBT computer program	Drug	MAT taper with placebo

Primary outcome

Change in Methadone/Buprenorphine Dose to 0 mg for Successful Completion of Taper
Time frame: during 10 weeks of study and up to 3 months after the end of opioid 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.

2 secondary outcomes

Clinical Opioid Withdrawal Scale (COWS)
Time frame: Data at week 0 (baseline) and week 10 (post treatment)
Substance Use Calendar
Time frame: during 10 weeks of study

Results and safety

Results posted to the registry on 19 Aug 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
MAT Taper With Galantamine	3	3
MAT Taper With Placebo	3	2

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

Time frame: during 10 weeks of study and up to 3 months after the end of opioid taper. Count of participants. Unit: Participants

Measure	MAT Taper With Galantamine n = 3	MAT Taper With Placebo n = 3
Value	3	2

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 10 weeks of taper. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
MAT Taper With Galantamine	0 of 3 (0%)	0 of 3 (0%)	0 of 3
MAT Taper With Placebo	0 of 3 (0%)	0 of 3 (0%)	0 of 3

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Kathleen M Carroll, PhD principal investigator

Yale University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing MAT taper with galantamine in people with Methadone or Buprenorphine Detoxoxification, run by Yale University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Aug 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Methadone/Buprenorphine Dose to 0 mg for Successful Completion of Taper (time frame: during 10 weeks of study and up to 3 months after the end of opioid taper). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03547622.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2022.