Trial Outcomes & Findings for Altering Memories That Increase Risk of Relapse in Alcohol Use Disorders (NCT NCT03732248)

Results Overview

Safety will be monitored through adverse events checks by the study physician assistant (PA). The study PA will use the Monitoring of Side-Effects Scale (MOSES) to track if there are any adverse effects. Participants will be recorded as those who report any adverse event vs. no adverse events.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

21 participants

Primary outcome timeframe

MOSES will be assessed at the first study visit on day 1.

Results posted on

2021-01-27

Participant Flow

Participant milestones

Participant milestones
Measure	Rapamycin (Sirolimus) 15mg Rapamycin (sirolimus) is administered in three 5mg oral capsules. This administration happens once during the first visit. Rapamycin: Immunosuppressive drug	Placebo Placebo is administered in three 5mg oral capsules. This administration happens once during the first visit. Placebo: Inert drug
Overall Study STARTED	11	10
Overall Study COMPLETED	10	10
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Rapamycin (Sirolimus) 15mg Rapamycin (sirolimus) is administered in three 5mg oral capsules. This administration happens once during the first visit. Rapamycin: Immunosuppressive drug	Placebo Placebo is administered in three 5mg oral capsules. This administration happens once during the first visit. Placebo: Inert drug
Overall Study Withdrawal by Subject	1	0

Baseline Characteristics

Altering Memories That Increase Risk of Relapse in Alcohol Use Disorders

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Rapamycin (Sirolimus) 15mg n=11 Participants Rapamycin (sirolimus) is administered in three 5mg oral capsules. This administration happens once during the first visit. Rapamycin: Immunosuppressive drug	Placebo n=10 Participants Placebo is administered in three 5mg oral capsules. This administration happens once during the first visit. Placebo: Inert drug	Total n=21 Participants Total of all reporting groups
Age, Continuous	43.1 years STANDARD_DEVIATION 9.9 • n=5 Participants	37.8 years STANDARD_DEVIATION 7.8 • n=7 Participants	40.6 years STANDARD_DEVIATION 9.2 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	5 Participants n=7 Participants	12 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	5 Participants n=7 Participants	9 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	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	11 Participants n=5 Participants	10 Participants n=7 Participants	21 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 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	11 participants n=5 Participants	10 participants n=7 Participants	21 participants n=5 Participants

PRIMARY outcome

Timeframe: MOSES will be assessed at the first study visit on day 1.

Safety will be monitored through adverse events checks by the study physician assistant (PA). The study PA will use the Monitoring of Side-Effects Scale (MOSES) to track if there are any adverse effects. Participants will be recorded as those who report any adverse event vs. no adverse events.

Outcome measures

Outcome measures
Measure	Rapamycin (Sirolimus) 15mg n=11 Participants Rapamycin (sirolimus) is administered in three 5mg oral capsules. This administration happens once during the first visit. Rapamycin: Immunosuppressive drug	Placebo n=10 Participants Placebo is administered in three 5mg oral capsules. This administration happens once during the first visit. Placebo: Inert drug
Evaluate Safety of a Single 15 mg Dose of Rapamycin (Sirolimus) at First Visit.	0 Participants	3 Participants

PRIMARY outcome

Timeframe: MOSES will be assessed at the second study visit, 24 hours after medication administration.

Safety will be monitored through adverse events checks by the study physician assistant (PA). The study PA will use the Monitoring of Side-Effects Scale (MOSES) to track if there are any adverse effects. Participants will be recorded as those who report any adverse event vs. no adverse events.

Outcome measures

Outcome measures
Measure	Rapamycin (Sirolimus) 15mg n=10 Participants Rapamycin (sirolimus) is administered in three 5mg oral capsules. This administration happens once during the first visit. Rapamycin: Immunosuppressive drug	Placebo n=10 Participants Placebo is administered in three 5mg oral capsules. This administration happens once during the first visit. Placebo: Inert drug
Evaluate Safety of Rapamycin (Sirolimus) at Second Visit.	2 Participants	6 Participants

PRIMARY outcome

Timeframe: MOSES will be assessed at the third study visit, approximately 10 days after medication administration.

Safety will be monitored through adverse events checks by the study physician assistant (PA). The study PA will use the Monitoring of Side-Effects Scale (MOSES) to track if there are any adverse effects. Participants will be recorded as those who report any adverse event vs. no adverse events.

Outcome measures

Outcome measures
Measure	Rapamycin (Sirolimus) 15mg n=10 Participants Rapamycin (sirolimus) is administered in three 5mg oral capsules. This administration happens once during the first visit. Rapamycin: Immunosuppressive drug	Placebo n=10 Participants Placebo is administered in three 5mg oral capsules. This administration happens once during the first visit. Placebo: Inert drug
Evaluate Safety of Rapamycin (Sirolimus) at Third (Last) Visit.	3 Participants	0 Participants

SECONDARY outcome

Timeframe: At participant's last study visit, approximately 10-14 days.

Participants will be given a timeline to record any drinking that occurs between visits 2 and 3. Time line follow back procedures were used to record daily drinking behavior for all study days; recorded as standard drinks. The total number of days where drinking was recorded is summed for each participants during the study window.

Outcome measures

Outcome measures
Measure	Rapamycin (Sirolimus) 15mg n=10 Participants Rapamycin (sirolimus) is administered in three 5mg oral capsules. This administration happens once during the first visit. Rapamycin: Immunosuppressive drug	Placebo n=10 Participants Placebo is administered in three 5mg oral capsules. This administration happens once during the first visit. Placebo: Inert drug
Drinking Days Between Visit 2 and Visit 3	10.5 Days Interval 4.0 to 12.0	8 Days Interval 5.0 to 10.0

SECONDARY outcome

Timeframe: At participant's last study visit, approximately 10 days.

Participants will be given a timeline to record any drinking that occurs between visits 2 and 3. Time line follow back procedures were used to record daily drinking behavior for all study days; recorded as standard drinks.

Outcome measures

Outcome measures
Measure	Rapamycin (Sirolimus) 15mg n=10 Participants Rapamycin (sirolimus) is administered in three 5mg oral capsules. This administration happens once during the first visit. Rapamycin: Immunosuppressive drug	Placebo n=10 Participants Placebo is administered in three 5mg oral capsules. This administration happens once during the first visit. Placebo: Inert drug
Drinks Per Drinking Day Between Visit 2 and Visit 3	4.8 Standard Drinks/day Standard Deviation 1.5	3.2 Standard Drinks/day Standard Deviation 2.2

SECONDARY outcome

Timeframe: At participant's last study visit, approximately 10 days.

Participants will be given a timeline to record any drinking that occurs between visits 2 and 3. Time line follow back procedures were used to record daily drinking behavior for all study days; recorded as standard drinks. Heavy drinking days are defined as \>=5 drinks per day for Males and \>=4 drinks per day for Females.

Outcome measures

Outcome measures
Measure	Rapamycin (Sirolimus) 15mg n=10 Participants Rapamycin (sirolimus) is administered in three 5mg oral capsules. This administration happens once during the first visit. Rapamycin: Immunosuppressive drug	Placebo n=10 Participants Placebo is administered in three 5mg oral capsules. This administration happens once during the first visit. Placebo: Inert drug
Heavy Drinking Days Between Visit 2 and Visit 3	5 Days Interval 2.0 to 11.0	2 Days Interval 2.0 to 4.0

Adverse Events

Rapamycin (Sirolimus) 15mg

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

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

Dr. Michael Saladin

Medical University of South Carolina

Phone: 843-792-5306

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place