Trial Outcomes & Findings for tDCS to Decrease Opioid Relapse (UG3) (NCT NCT03842137)
NCT ID: NCT03842137
Last Updated: 2024-10-24
Results Overview
Penn Alcohol Craving (Modified for Opioids). This is a 5-item measure, with each item scored 0 to 6. Items are summed for a total score from 0 to 30. Higher scores = more craving.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
62 participants
Primary outcome timeframe
2 week
Results posted on
2024-10-24
Participant Flow
Participant recruitment started June 4, 2019 and was completed on 2/21/23. Participants were recruited from both clinical settings and through community advertisements.
Once enrolled, participants were randomized at the beginning of their first tDCS session. If they did not attend that session, they were never randomized/assigned to a condition.
Participant milestones
| Measure |
tDCS
Each participant will undergo 5 consecutive (i.e., business days) sessions of active tDCS delivered to the DLPFC. During each session, participants are engaging in tasks that activate the cognitive control network.
tDCS: Each participant will undergo 5 consecutive (i.e., business days) sessions of active tDCS delivered to the DLPFC. During each session, participants are engaging in tasks that activate the cognitive control network.
|
Sham tDCS
Each participant will undergo 5 consecutive (i.e., business days) sessions of sham tDCS delivered to the DLPFC. During each session, participants are engaging in tasks that activate the cognitive control network.
sham tDCS: Each participant will undergo 5 consecutive (i.e., business days) sessions of sham tDCS delivered to the DLPFC. During each session, participants are engaging in tasks that activate the cognitive control network.
|
|---|---|---|
|
Overall Study
STARTED
|
27
|
27
|
|
Overall Study
COMPLETED
|
26
|
25
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
tDCS to Decrease Opioid Relapse (UG3)
Baseline characteristics by cohort
| Measure |
tDCS
n=27 Participants
Each participant will undergo 5 consecutive (i.e., business days) sessions of active tDCS delivered to the DLPFC. During each session, participants are engaging in tasks that activate the cognitive control network.
tDCS: Each participant will undergo 5 consecutive (i.e., business days) sessions of active tDCS delivered to the DLPFC. During each session, participants are engaging in tasks that activate the cognitive control network.
|
Sham tDCS
n=27 Participants
Each participant will undergo 5 consecutive (i.e., business days) sessions of sham tDCS delivered to the DLPFC. During each session, participants are engaging in tasks that activate the cognitive control network.
sham tDCS: Each participant will undergo 5 consecutive (i.e., business days) sessions of sham tDCS delivered to the DLPFC. During each session, participants are engaging in tasks that activate the cognitive control network.
|
Not Randomized
n=8 Participants
Participants were randomized at the beginning of their first tDCS session. Enrolled participants who did not attend their first session (n=8) were never randomized.
|
Total
n=62 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Sex: Female, Male
Male
|
18 Participants
n=93 Participants
|
13 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
37 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
7 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
23 Participants
n=93 Participants
|
24 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
55 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Age, Continuous
|
33.19 years
STANDARD_DEVIATION 7.44 • n=93 Participants
|
34.48 years
STANDARD_DEVIATION 7.91 • n=4 Participants
|
35.75 years
STANDARD_DEVIATION 10.38 • n=27 Participants
|
34.08 years
STANDARD_DEVIATION 7.96 • n=483 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=93 Participants
|
14 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
25 Participants
n=483 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
6 Participants
n=483 Participants
|
|
Race (NIH/OMB)
White
|
23 Participants
n=93 Participants
|
22 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
50 Participants
n=483 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
|
Region of Enrollment
United States
|
27 participants
n=93 Participants
|
27 participants
n=4 Participants
|
8 participants
n=27 Participants
|
62 participants
n=483 Participants
|
|
Opioid Craving
|
11.07 units on a scale
STANDARD_DEVIATION 8.39 • n=93 Participants
|
8.85 units on a scale
STANDARD_DEVIATION 7.84 • n=4 Participants
|
8.75 units on a scale
STANDARD_DEVIATION 8.88 • n=27 Participants
|
9.81 units on a scale
STANDARD_DEVIATION 8.12 • n=483 Participants
|
PRIMARY outcome
Timeframe: 2 weekPenn Alcohol Craving (Modified for Opioids). This is a 5-item measure, with each item scored 0 to 6. Items are summed for a total score from 0 to 30. Higher scores = more craving.
Outcome measures
| Measure |
tDCS
n=26 Participants
Each participant will undergo 5 consecutive (i.e., business days) sessions of active tDCS delivered to the DLPFC. During each session, participants are engaging in tasks that activate the cognitive control network.
tDCS: Each participant will undergo 5 consecutive (i.e., business days) sessions of active tDCS delivered to the DLPFC. During each session, participants are engaging in tasks that activate the cognitive control network.
|
Sham tDCS
n=25 Participants
Each participant will undergo 5 consecutive (i.e., business days) sessions of sham tDCS delivered to the DLPFC. During each session, participants are engaging in tasks that activate the cognitive control network.
sham tDCS: Each participant will undergo 5 consecutive (i.e., business days) sessions of sham tDCS delivered to the DLPFC. During each session, participants are engaging in tasks that activate the cognitive control network.
|
|---|---|---|
|
Opioid Craving
|
8.92 units on a scale
Standard Deviation 1.10
|
8.32 units on a scale
Standard Deviation 1.12
|
SECONDARY outcome
Timeframe: 2 weeksPopulation: theta burst rate (per second) during the 2-back delay part of the working memory task
Theta event rate is examined as the number of times/second that brainwaves within the theta frequency range (4-7 Hz). Higher event rates reflect more activity during working memory task.
Outcome measures
| Measure |
tDCS
n=22 Participants
Each participant will undergo 5 consecutive (i.e., business days) sessions of active tDCS delivered to the DLPFC. During each session, participants are engaging in tasks that activate the cognitive control network.
tDCS: Each participant will undergo 5 consecutive (i.e., business days) sessions of active tDCS delivered to the DLPFC. During each session, participants are engaging in tasks that activate the cognitive control network.
|
Sham tDCS
n=20 Participants
Each participant will undergo 5 consecutive (i.e., business days) sessions of sham tDCS delivered to the DLPFC. During each session, participants are engaging in tasks that activate the cognitive control network.
sham tDCS: Each participant will undergo 5 consecutive (i.e., business days) sessions of sham tDCS delivered to the DLPFC. During each session, participants are engaging in tasks that activate the cognitive control network.
|
|---|---|---|
|
EEG Theta Brainwave Activity
|
.38 events per second
Standard Deviation .06
|
.33 events per second
Standard Deviation .05
|
Adverse Events
tDCS
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Sham tDCS
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
tDCS
n=27 participants at risk
Each participant will undergo 5 consecutive (i.e., business days) sessions of active tDCS delivered to the DLPFC. During each session, participants are engaging in tasks that activate the cognitive control network.
tDCS: Each participant will undergo 5 consecutive (i.e., business days) sessions of active tDCS delivered to the DLPFC. During each session, participants are engaging in tasks that activate the cognitive control network.
|
Sham tDCS
n=27 participants at risk
Each participant will undergo 5 consecutive (i.e., business days) sessions of sham tDCS delivered to the DLPFC. During each session, participants are engaging in tasks that activate the cognitive control network.
sham tDCS: Each participant will undergo 5 consecutive (i.e., business days) sessions of sham tDCS delivered to the DLPFC. During each session, participants are engaging in tasks that activate the cognitive control network.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/27 • 2-weeks
|
3.7%
1/27 • Number of events 1 • 2-weeks
|
|
General disorders
Headache
|
0.00%
0/27 • 2-weeks
|
3.7%
1/27 • Number of events 1 • 2-weeks
|
|
Skin and subcutaneous tissue disorders
Head Itchiness
|
3.7%
1/27 • Number of events 1 • 2-weeks
|
0.00%
0/27 • 2-weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place