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Galantamine and CBT4CBT Pilot

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ClinicalTrials.gov Identifier: NCT03547622
Recruitment Status : Active, not recruiting
First Posted : June 6, 2018
Last Update Posted : January 30, 2019
Sponsor:
Information provided by (Responsible Party):
Yale University

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.

Condition or disease Intervention/treatment Phase
Methadone or Buprenorphine Detoxoxification Drug: MAT taper with galantamine Drug: MAT taper with placebo Early Phase 1

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).


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Pilot Study of Galantamine and CBT4CBT to Reduce Post-taper Relapse for MAT
Actual Study Start Date : May 1, 2018
Estimated Primary Completion Date : February 28, 2019
Estimated Study Completion Date : February 28, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: MAT taper with galantamine
Following initial MAT taper, participants will be given up to 16mg daily of galantamine for up to 10 weeks of the active study
Drug: MAT taper with galantamine
Following taper from MAT (methadone or buprenorphine) participants will be given galantamine daily with access to a CBT4CBT computer program

Placebo Comparator: MAT taper with placebo
Following initial MAT taper, participants will be given up to 16mg daily of placebo for up to 10 weeks of the active study
Drug: MAT taper with placebo
Following taper from MAT (methadone or buprenorphine) participants will be given placebo daily with access to a CBT4CBT computer program




Primary Outcome Measures :
  1. Change in methadone/buprenorphine dose for successful completion of taper [ Time Frame: during 10 weeks of study and up to 3 months after the end of opioid taper ]
    achieving a methadone/buprenorphine dose of 0


Secondary Outcome Measures :
  1. Clinical Opioid Withdrawal Scale (COWS) [ Time Frame: during 10 weeks of study and up to 3 months after the end of opioid taper ]
    opioid withdrawal symptoms

  2. Substance Use Calendar [ Time Frame: during 10 weeks of study and up to 3 months after the end of opioid taper ]
    opioid use, assessed by self-report and urine samples



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03547622


Locations
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United States, Connecticut
APT Foundation
New Haven, Connecticut, United States, 06511
Sponsors and Collaborators
Yale University
Investigators
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Principal Investigator: Kathleen M Carroll, PhD Yale University

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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT03547622     History of Changes
Other Study ID Numbers: 20000 21868
First Posted: June 6, 2018    Key Record Dates
Last Update Posted: January 30, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Galantamine
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Parasympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Nootropic Agents