Trial Outcomes & Findings for Pharmacologically-based Strategies for Opioid Substitution Therapy During Pregnancy (NCT NCT03831113)
NCT ID: NCT03831113
Last Updated: 2024-08-29
Results Overview
The VAS questionnaire consists of 4 questions related to cravings (0 = not at all to 10 = very much), withdrawal (0 = no symptoms to 10 = symptoms all day), sleep quality (0 = best to 10 = worst), and sleep duration (0 = longest ever to 10 = shortest ever). The 4 component questions are summed to provide a single VAS score for that day. The daily scores are averaged over the week or for two weeks depending on how often the dose was changed. The average VAS scores for each reduction regimen are averaged and compared to the alternative dosing group.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
13 participants
Primary outcome timeframe
36 weeks
Results posted on
2024-08-29
Participant Flow
Recruitment occurred in two Medication Assisted Treatment clinics either in Pittsburgh or in Knoxville.Recruitment started on 4/13/2019 and ended on 12/22/2022. All participants at the Tennessee site were assigned to the frequency group
Participant milestones
| Measure |
Magnitude Group
Subjects will alternately reduce dose by 1 mg/week then 2 mg/week. This will be repeated until the lowest tolerable dose is achieved. VAS scores during the 1 mg /week period will be recorded and compared to the VAS scores during the 2 mg/ week reduction.
|
Frequency Group
Subjects will alternately reduce dose by 2 mg/week then 2 mg every 2 weeks. This will be repeated until the lowest tolerable dose is achieved. VAS scores during the 2 mg /week period will be recorded and compared to the VAS scores during the 2 mg every 2 week reduction.
|
|---|---|---|
|
Overall Study
STARTED
|
1
|
12
|
|
Overall Study
COMPLETED
|
1
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
11
|
Reasons for withdrawal
| Measure |
Magnitude Group
Subjects will alternately reduce dose by 1 mg/week then 2 mg/week. This will be repeated until the lowest tolerable dose is achieved. VAS scores during the 1 mg /week period will be recorded and compared to the VAS scores during the 2 mg/ week reduction.
|
Frequency Group
Subjects will alternately reduce dose by 2 mg/week then 2 mg every 2 weeks. This will be repeated until the lowest tolerable dose is achieved. VAS scores during the 2 mg /week period will be recorded and compared to the VAS scores during the 2 mg every 2 week reduction.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
|
Overall Study
Protocol Violation
|
0
|
9
|
Baseline Characteristics
protocol violations, drop outs and non-compliance led to non analysis of 11 subjects
Baseline characteristics by cohort
| Measure |
Magnitude Group
n=1 Participants
Subjects will receive alternating reductions of 1 mg and then 2 mg weekly. Dose reductions will continue until the subject is no longer taking buprenorphine or is at the lowest tolerable dose.
|
Frequency Group
n=12 Participants
Subjects will receive dose reductions of 2 mg on alternating intervals of 1 and 2 weeks. Dose reductions will continue until the subject is no longer taking buprenorphine or is at the lowest tolerable dose.
|
Total
n=13 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
26 years
STANDARD_DEVIATION 0 • n=1 Participants
|
32.4 years
STANDARD_DEVIATION 6.1 • n=12 Participants
|
31.8 years
STANDARD_DEVIATION 6.1 • n=13 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=1 Participants • protocol violations, drop outs and non-compliance led to non analysis of 11 subjects
|
1 Participants
n=1 Participants • protocol violations, drop outs and non-compliance led to non analysis of 11 subjects
|
2 Participants
n=2 Participants • protocol violations, drop outs and non-compliance led to non analysis of 11 subjects
|
|
Sex: Female, Male
Male
|
0 Participants
n=1 Participants • protocol violations, drop outs and non-compliance led to non analysis of 11 subjects
|
0 Participants
n=1 Participants • protocol violations, drop outs and non-compliance led to non analysis of 11 subjects
|
0 Participants
n=2 Participants • protocol violations, drop outs and non-compliance led to non analysis of 11 subjects
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=1 Participants • protocol violations, drop outs and non-compliance led to non analysis of 11 subjects
|
0 Participants
n=1 Participants • protocol violations, drop outs and non-compliance led to non analysis of 11 subjects
|
0 Participants
n=2 Participants • protocol violations, drop outs and non-compliance led to non analysis of 11 subjects
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=1 Participants • protocol violations, drop outs and non-compliance led to non analysis of 11 subjects
|
1 Participants
n=1 Participants • protocol violations, drop outs and non-compliance led to non analysis of 11 subjects
|
2 Participants
n=2 Participants • protocol violations, drop outs and non-compliance led to non analysis of 11 subjects
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=1 Participants • protocol violations, drop outs and non-compliance led to non analysis of 11 subjects
|
0 Participants
n=1 Participants • protocol violations, drop outs and non-compliance led to non analysis of 11 subjects
|
0 Participants
n=2 Participants • protocol violations, drop outs and non-compliance led to non analysis of 11 subjects
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=1 Participants • difference between analyzed vs recruited due to non- compliance , drop out or protocol violations
|
0 Participants
n=1 Participants • difference between analyzed vs recruited due to non- compliance , drop out or protocol violations
|
0 Participants
n=2 Participants • difference between analyzed vs recruited due to non- compliance , drop out or protocol violations
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=1 Participants • difference between analyzed vs recruited due to non- compliance , drop out or protocol violations
|
0 Participants
n=1 Participants • difference between analyzed vs recruited due to non- compliance , drop out or protocol violations
|
0 Participants
n=2 Participants • difference between analyzed vs recruited due to non- compliance , drop out or protocol violations
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=1 Participants • difference between analyzed vs recruited due to non- compliance , drop out or protocol violations
|
0 Participants
n=1 Participants • difference between analyzed vs recruited due to non- compliance , drop out or protocol violations
|
0 Participants
n=2 Participants • difference between analyzed vs recruited due to non- compliance , drop out or protocol violations
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=1 Participants • difference between analyzed vs recruited due to non- compliance , drop out or protocol violations
|
0 Participants
n=1 Participants • difference between analyzed vs recruited due to non- compliance , drop out or protocol violations
|
0 Participants
n=2 Participants • difference between analyzed vs recruited due to non- compliance , drop out or protocol violations
|
|
Race (NIH/OMB)
White
|
1 Participants
n=1 Participants • difference between analyzed vs recruited due to non- compliance , drop out or protocol violations
|
1 Participants
n=1 Participants • difference between analyzed vs recruited due to non- compliance , drop out or protocol violations
|
2 Participants
n=2 Participants • difference between analyzed vs recruited due to non- compliance , drop out or protocol violations
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=1 Participants • difference between analyzed vs recruited due to non- compliance , drop out or protocol violations
|
0 Participants
n=1 Participants • difference between analyzed vs recruited due to non- compliance , drop out or protocol violations
|
0 Participants
n=2 Participants • difference between analyzed vs recruited due to non- compliance , drop out or protocol violations
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=1 Participants • difference between analyzed vs recruited due to non- compliance , drop out or protocol violations
|
0 Participants
n=1 Participants • difference between analyzed vs recruited due to non- compliance , drop out or protocol violations
|
0 Participants
n=2 Participants • difference between analyzed vs recruited due to non- compliance , drop out or protocol violations
|
PRIMARY outcome
Timeframe: 36 weeksPopulation: only those compliant with protocol were analyzed
The VAS questionnaire consists of 4 questions related to cravings (0 = not at all to 10 = very much), withdrawal (0 = no symptoms to 10 = symptoms all day), sleep quality (0 = best to 10 = worst), and sleep duration (0 = longest ever to 10 = shortest ever). The 4 component questions are summed to provide a single VAS score for that day. The daily scores are averaged over the week or for two weeks depending on how often the dose was changed. The average VAS scores for each reduction regimen are averaged and compared to the alternative dosing group.
Outcome measures
| Measure |
Magnitude Group
n=1 Participants
Group had dose reduced alternately by 1 or 2 mg weekly
|
Frequency Group
n=1 Participants
participants reduced their dose by 2 mg either weekly or biweekly
|
|---|---|---|
|
Visual Analog Scale (VAS) Scores
1 mg or 1 week cycle
|
2.11 score on a scale
Standard Deviation .12
|
.43 score on a scale
Standard Deviation .13
|
|
Visual Analog Scale (VAS) Scores
2 mg or 2 week cycle
|
1.94 score on a scale
Standard Deviation .23
|
.43 score on a scale
Standard Deviation .13
|
Adverse Events
Magnitude Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Frequency Group
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