Trial Outcomes & Findings for Frontal-Striatal Reward Circuit Neuromodulation and Alcohol Self-Administration (NCT NCT04971681)
NCT ID: NCT04971681
Last Updated: 2025-01-13
Results Overview
The amount of time subjects take to self-administer enough alcohol to raise their breath alcohol concentration (BrAC) to 80 mg/dL
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
9 participants
Primary outcome timeframe
90 min
Results posted on
2025-01-13
Participant Flow
Healthy men and women were recruited from past participants consented to be contacted for future studies, through flyers placed on public bulletin boards, and through ads placed in a local emailed jobs list. Minimum criteria included age 21-35 and consumption of at least 4 drinks/day on at least 2 days in a recent 35 day period
Participant milestones
| Measure |
Active rTMS Condition First, Then Sham rTMS
Subjects will undergo 2 sessions, one active rTMS, one sham, one week apart.
Active session: subjects will receive low frequency repetitive transcranial magnetic stimulation (rTMS) targeting the medial prefrontal cortex (mPFC). The stimulus will consist of a continuous 20-minute train of 1 Hz rTMS, at 110% of motor threshold (MT), for a total of 1200 pulses.
|
Sham rTMS Stimulation, Then Active rTMS
Subjects will undergo 2 sessions, one active rTMS, one sham, one week apart.
Sham session: All procedures identical except that rTMS will not be delivered. The sham treatment mimics cutaneous stimulation, facilitating double-blinding.
|
|---|---|---|
|
First Intervention
STARTED
|
4
|
5
|
|
First Intervention
COMPLETED
|
4
|
5
|
|
First Intervention
NOT COMPLETED
|
0
|
0
|
|
Washout (7-14 Days)
STARTED
|
4
|
5
|
|
Washout (7-14 Days)
COMPLETED
|
4
|
5
|
|
Washout (7-14 Days)
NOT COMPLETED
|
0
|
0
|
|
Second Intervention
STARTED
|
4
|
5
|
|
Second Intervention
COMPLETED
|
4
|
5
|
|
Second Intervention
NOT COMPLETED
|
0
|
0
|
|
Followup
STARTED
|
4
|
5
|
|
Followup
COMPLETED
|
3
|
5
|
|
Followup
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Active rTMS Condition First, Then Sham rTMS
Subjects will undergo 2 sessions, one active rTMS, one sham, one week apart.
Active session: subjects will receive low frequency repetitive transcranial magnetic stimulation (rTMS) targeting the medial prefrontal cortex (mPFC). The stimulus will consist of a continuous 20-minute train of 1 Hz rTMS, at 110% of motor threshold (MT), for a total of 1200 pulses.
|
Sham rTMS Stimulation, Then Active rTMS
Subjects will undergo 2 sessions, one active rTMS, one sham, one week apart.
Sham session: All procedures identical except that rTMS will not be delivered. The sham treatment mimics cutaneous stimulation, facilitating double-blinding.
|
|---|---|---|
|
Followup
Lost to Follow-up
|
1
|
0
|
Baseline Characteristics
Frontal-Striatal Reward Circuit Neuromodulation and Alcohol Self-Administration
Baseline characteristics by cohort
| Measure |
Active rTMS First
n=4 Participants
Subjects counterbalanced to session order Active rTMS-Sham rTMS
|
Sham rTMS First
n=5 Participants
Subjects counterbalanced to order Sham rTMS-Active rTMS
|
Total
n=9 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Age 21-35 years
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=5 Participants
|
5 participants
n=7 Participants
|
9 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 90 minThe amount of time subjects take to self-administer enough alcohol to raise their breath alcohol concentration (BrAC) to 80 mg/dL
Outcome measures
| Measure |
Low Frequency Repetitive Transcranial Magnetic Stimulation (rTMS)
n=9 Participants
Subjects will receive one session of low frequency repetitive transcranial magnetic stimulation (rTMS) targeting the medial prefrontal cortex (mPFC), within the following stimulation parameters: Continuous 20-minute train of 1 Hz rTMS, at 110% of motor threshold (MT), for a total of 1200 pulses. Session order is counterbalanced.
|
Sham rTMS Stimulation
n=9 Participants
Subjects will receive one session of sham stimulation. The active and sham functions share the same acoustic properties and sham mimics cutaneous stimulation, facilitating double-blinding. Session order is counterbalanced.
|
|---|---|---|
|
T80
|
61.5 Minutes
Standard Error 9.4
|
71.6 Minutes
Standard Error 8.0
|
SECONDARY outcome
Timeframe: 5 weeksAlcohol consumption as measured by Time Line Follow Back (TLFB) comparing drinking baseline (5 weeks prior to study) with post-treatment during the 5-week follow-up period. The Timeline Follow-back (TLFB) is uses a calendar to assess a subject's retrospective estimates of their daily drinking.
Outcome measures
| Measure |
Low Frequency Repetitive Transcranial Magnetic Stimulation (rTMS)
n=8 Participants
Subjects will receive one session of low frequency repetitive transcranial magnetic stimulation (rTMS) targeting the medial prefrontal cortex (mPFC), within the following stimulation parameters: Continuous 20-minute train of 1 Hz rTMS, at 110% of motor threshold (MT), for a total of 1200 pulses. Session order is counterbalanced.
|
Sham rTMS Stimulation
n=8 Participants
Subjects will receive one session of sham stimulation. The active and sham functions share the same acoustic properties and sham mimics cutaneous stimulation, facilitating double-blinding. Session order is counterbalanced.
|
|---|---|---|
|
Alcohol Consumption (Drinks/Week)
|
14.8 Drinks/week
Standard Error 4.9
|
7.8 Drinks/week
Standard Error 3.5
|
Adverse Events
Low Frequency Repetitive Transcranial Magnetic Stimulation (rTMS)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sham rTMS Stimulation
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