Trial Outcomes & Findings for Galantamine and CBT4CBT Pilot to Prevent Relapse. (NCT NCT03547622)
NCT ID: NCT03547622
Last Updated: 2022-08-19
Results Overview
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.
Recruitment status
COMPLETED
Study phase
EARLY_PHASE1
Target enrollment
6 participants
Primary outcome timeframe
during 10 weeks of study and up to 3 months after the end of opioid taper
Results posted on
2022-08-19
Participant Flow
Participant milestones
| Measure |
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
MAT taper with galantamine: Following taper from MAT (methadone or buprenorphine) participants will be given galantamine daily with access to a CBT4CBT computer program
|
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
MAT taper with placebo: Following taper from MAT (methadone or buprenorphine) participants will be given placebo daily with access to a CBT4CBT computer program
|
|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
|
Overall Study
COMPLETED
|
3
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Participants could be taking either Methadone or Buprenorphine for the study and dose in mg differs for the two medications.
Baseline characteristics by cohort
| Measure |
MAT Taper With Galantamine
n=3 Participants
Following 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 galantamine: Following taper from MAT (methadone or buprenorphine) participants will be given galantamine daily with access to a CBT4CBT computer program
|
MAT Taper With Placebo
n=3 Participants
Following initial MAT taper, participants will be given up to 16mg daily of placebo for up to 10 weeks of the active study
MAT taper with placebo: Following taper from MAT (methadone or buprenorphine) participants will be given placebo daily with access to a CBT4CBT computer program
|
Total
n=6 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
39.3 years
STANDARD_DEVIATION 19.7 • n=3 Participants
|
48.3 years
STANDARD_DEVIATION 17.6 • n=3 Participants
|
43.8 years
STANDARD_DEVIATION 17.4 • n=6 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=3 Participants
|
2 Participants
n=3 Participants
|
5 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=3 Participants
|
1 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=3 Participants
|
3 Participants
n=3 Participants
|
5 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=3 Participants
|
1 Participants
n=3 Participants
|
2 Participants
n=6 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=3 Participants
|
2 Participants
n=3 Participants
|
4 Participants
n=6 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=3 Participants
|
3 participants
n=3 Participants
|
6 participants
n=6 Participants
|
|
Medication dose-Methadone
|
20 mg
n=1 Participants • Participants could be taking either Methadone or Buprenorphine for the study and dose in mg differs for the two medications.
|
13.0 mg
STANDARD_DEVIATION 1.4 • n=2 Participants • Participants could be taking either Methadone or Buprenorphine for the study and dose in mg differs for the two medications.
|
15.3 mg
STANDARD_DEVIATION 4.1 • n=3 Participants • Participants could be taking either Methadone or Buprenorphine for the study and dose in mg differs for the two medications.
|
|
Medication dose-Buprenorphine
|
2.5 mg
STANDARD_DEVIATION 2.1 • n=2 Participants • Participants could be taking either Methadone or Buprenorphine for the study and dose in mg differs for the two medications.
|
2.0 mg
n=1 Participants • Participants could be taking either Methadone or Buprenorphine for the study and dose in mg differs for the two medications.
|
2.3 mg
STANDARD_DEVIATION 1.5 • n=3 Participants • Participants could be taking either Methadone or Buprenorphine for the study and dose in mg differs for the two medications.
|
PRIMARY outcome
Timeframe: during 10 weeks of study and up to 3 months after the end of opioid taperNumber 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.
Outcome measures
| Measure |
MAT Taper With Galantamine
n=3 Participants
Following 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 galantamine: Following taper from MAT (methadone or buprenorphine) participants will be given galantamine daily with access to a CBT4CBT computer program
|
MAT Taper With Placebo
n=3 Participants
Following initial MAT taper, participants will be given up to 16mg daily of placebo for up to 10 weeks of the active study
MAT taper with placebo: Following taper from MAT (methadone or buprenorphine) participants will be given placebo daily with access to a CBT4CBT computer program
|
|---|---|---|
|
Change in Methadone/Buprenorphine Dose to 0 mg for Successful Completion of Taper
|
3 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Data at week 0 (baseline) and week 10 (post treatment)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).
Outcome measures
| Measure |
MAT Taper With Galantamine
n=3 Participants
Following 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 galantamine: Following taper from MAT (methadone or buprenorphine) participants will be given galantamine daily with access to a CBT4CBT computer program
|
MAT Taper With Placebo
n=3 Participants
Following initial MAT taper, participants will be given up to 16mg daily of placebo for up to 10 weeks of the active study
MAT taper with placebo: Following taper from MAT (methadone or buprenorphine) participants will be given placebo daily with access to a CBT4CBT computer program
|
|---|---|---|
|
Clinical Opioid Withdrawal Scale (COWS)
Week 0 (baseline) Score
|
0 score on a scale
Standard Deviation 0
|
.33 score on a scale
Standard Deviation .58
|
|
Clinical Opioid Withdrawal Scale (COWS)
Week 10 (Post Treatment Score)
|
4.3 score on a scale
Standard Deviation 5.1
|
4.2 score on a scale
Standard Deviation 4.1
|
SECONDARY outcome
Timeframe: during 10 weeks of studynumber of days of opioid use, assessed by self-report
Outcome measures
| Measure |
MAT Taper With Galantamine
n=3 Participants
Following 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 galantamine: Following taper from MAT (methadone or buprenorphine) participants will be given galantamine daily with access to a CBT4CBT computer program
|
MAT Taper With Placebo
n=3 Participants
Following initial MAT taper, participants will be given up to 16mg daily of placebo for up to 10 weeks of the active study
MAT taper with placebo: Following taper from MAT (methadone or buprenorphine) participants will be given placebo daily with access to a CBT4CBT computer program
|
|---|---|---|
|
Substance Use Calendar
|
1.0 Days
Standard Deviation 1.73
|
0 Days
Standard Deviation 0
|
Adverse Events
MAT Taper With Galantamine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
MAT Taper With Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place