Trial Outcomes & Findings for Medication Development in Alcoholism: Apremilast Versus Placebo (NCT NCT03175549)
NCT ID: NCT03175549
Last Updated: 2022-09-16
Results Overview
Total Visual Analog Scale (VAS) scores of craving severity in response to in vivo alcohol cues. Higher scores indicate greater craving severity with a minimum score of 0 and a maximum score of 80.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
51 participants
Primary outcome timeframe
1 hour on the last day of dosing (Day 14)
Results posted on
2022-09-16
Participant Flow
Subjects were recruited for study participation at the Laboratory of Clinical Psychopharmacology at The Scripps Research Institute in La Jolla, CA from 11/01/2017-04/01/2020. Seventy-seven non-treatment seeking, paid volunteers signed informed consent, Fifty-one subjects were enrolled, and Forty-three subjects completed the study.
Twenty-six subjects were excluded from study participation, twenty-two did not meet admission criteria and four declined to participate.
Participant milestones
| Measure |
Apremilast (Otezla)
Fixed oral dose of 90 mg/d following standard titration for a total duration of 14 days.
|
Placebo
Placebo pill taken orally for 14 days
Placebo: Oral pill, 14 days
|
|---|---|---|
|
Overall Study
STARTED
|
26
|
25
|
|
Overall Study
COMPLETED
|
22
|
21
|
|
Overall Study
NOT COMPLETED
|
4
|
4
|
Reasons for withdrawal
| Measure |
Apremilast (Otezla)
Fixed oral dose of 90 mg/d following standard titration for a total duration of 14 days.
|
Placebo
Placebo pill taken orally for 14 days
Placebo: Oral pill, 14 days
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
2
|
|
Overall Study
Medication non-compliance
|
2
|
2
|
Baseline Characteristics
Medication Development in Alcoholism: Apremilast Versus Placebo
Baseline characteristics by cohort
| Measure |
Apremilast (Otezla)
n=26 Participants
Fixed oral dose of 90 mg/d following the standard titration for a total dosing duration of 14 days.
|
Placebo
n=25 Participants
Placebo pill taken orally for 14 days
|
Total
n=51 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
39.12 years
STANDARD_DEVIATION 13.9 • n=93 Participants
|
43.3 years
STANDARD_DEVIATION 18.5 • n=4 Participants
|
41.16 years
STANDARD_DEVIATION 16.3 • n=27 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
24 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=93 Participants
|
16 Participants
n=4 Participants
|
27 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
24 Participants
n=93 Participants
|
20 Participants
n=4 Participants
|
44 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=93 Participants
|
23 Participants
n=4 Participants
|
43 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
26 participants
n=93 Participants
|
25 participants
n=4 Participants
|
51 participants
n=27 Participants
|
|
DSM-V symptom count
|
6.58 Symptom count
STANDARD_DEVIATION 2.2 • n=93 Participants
|
6.24 Symptom count
STANDARD_DEVIATION 2.4 • n=4 Participants
|
6.41 Symptom count
STANDARD_DEVIATION 2.3 • n=27 Participants
|
PRIMARY outcome
Timeframe: 1 hour on the last day of dosing (Day 14)Population: All subjects who completed cue exposure testing in the laboratory were included.
Total Visual Analog Scale (VAS) scores of craving severity in response to in vivo alcohol cues. Higher scores indicate greater craving severity with a minimum score of 0 and a maximum score of 80.
Outcome measures
| Measure |
Apremilast (Otezla)
n=21 Participants
Fixed oral dose of 90 mg/d following standard titration for a total duration of 14 days.
|
Placebo
n=20 Participants
Placebo pill taken orally for 14 days
Placebo: Oral pill, 14 days
|
|---|---|---|
|
Craving to Drink
|
33.84 score on a scale
Interval 14.03 to 53.73
|
28.31 score on a scale
Interval 8.34 to 48.11
|
SECONDARY outcome
Timeframe: 11 days (Treatment effects on drinking were accessed during the 11 days of ad libidum and did not include the final three days of mandatory abstinence prior to cue reactivity testing on day 14 of dosing.)Population: All subjects with post baseline drinking data were included.
Number of standard drinks per day using the Timeline Followback Interview (TLFB). Total number of alcoholic drinks consumed per day with a minimum value of 0 and an undetermined maximum value. Treatment effects on drinking were accessed during the 11 days of ad libidum and did not include the final three days of mandatory abstinence prior to cue reactivity testing on day 14 of dosing.
Outcome measures
| Measure |
Apremilast (Otezla)
n=22 Participants
Fixed oral dose of 90 mg/d following standard titration for a total duration of 14 days.
|
Placebo
n=21 Participants
Placebo pill taken orally for 14 days
Placebo: Oral pill, 14 days
|
|---|---|---|
|
Drinking
|
3.71 Drinks per day
Standard Error 0.82
|
3.92 Drinks per day
Standard Error 0.82
|
Adverse Events
Apremilast (Otezla)
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Apremilast (Otezla)
n=26 participants at risk
Fixed oral dose of 90 mg/d following the standard titration for a total dosing duration of 14 days.
|
Placebo
n=25 participants at risk
Placebo pill taken orally for 14 days
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
15.4%
4/26 • Adverse event data was collected at all study visits, for an average duration of 4 weeks (2 weeks on drug, and 2 weeks post treatment).
Adverse events, both serious and other, were documented at all study visits by the Medical Assistant on the adverse events case report form.
|
0.00%
0/25 • Adverse event data was collected at all study visits, for an average duration of 4 weeks (2 weeks on drug, and 2 weeks post treatment).
Adverse events, both serious and other, were documented at all study visits by the Medical Assistant on the adverse events case report form.
|
|
Gastrointestinal disorders
Diarrhea
|
34.6%
9/26 • Adverse event data was collected at all study visits, for an average duration of 4 weeks (2 weeks on drug, and 2 weeks post treatment).
Adverse events, both serious and other, were documented at all study visits by the Medical Assistant on the adverse events case report form.
|
16.0%
4/25 • Adverse event data was collected at all study visits, for an average duration of 4 weeks (2 weeks on drug, and 2 weeks post treatment).
Adverse events, both serious and other, were documented at all study visits by the Medical Assistant on the adverse events case report form.
|
|
Gastrointestinal disorders
Nausea
|
42.3%
11/26 • Adverse event data was collected at all study visits, for an average duration of 4 weeks (2 weeks on drug, and 2 weeks post treatment).
Adverse events, both serious and other, were documented at all study visits by the Medical Assistant on the adverse events case report form.
|
16.0%
4/25 • Adverse event data was collected at all study visits, for an average duration of 4 weeks (2 weeks on drug, and 2 weeks post treatment).
Adverse events, both serious and other, were documented at all study visits by the Medical Assistant on the adverse events case report form.
|
|
General disorders
Hangover
|
15.4%
4/26 • Adverse event data was collected at all study visits, for an average duration of 4 weeks (2 weeks on drug, and 2 weeks post treatment).
Adverse events, both serious and other, were documented at all study visits by the Medical Assistant on the adverse events case report form.
|
12.0%
3/25 • Adverse event data was collected at all study visits, for an average duration of 4 weeks (2 weeks on drug, and 2 weeks post treatment).
Adverse events, both serious and other, were documented at all study visits by the Medical Assistant on the adverse events case report form.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
7.7%
2/26 • Adverse event data was collected at all study visits, for an average duration of 4 weeks (2 weeks on drug, and 2 weeks post treatment).
Adverse events, both serious and other, were documented at all study visits by the Medical Assistant on the adverse events case report form.
|
12.0%
3/25 • Adverse event data was collected at all study visits, for an average duration of 4 weeks (2 weeks on drug, and 2 weeks post treatment).
Adverse events, both serious and other, were documented at all study visits by the Medical Assistant on the adverse events case report form.
|
|
Nervous system disorders
Headache
|
38.5%
10/26 • Adverse event data was collected at all study visits, for an average duration of 4 weeks (2 weeks on drug, and 2 weeks post treatment).
Adverse events, both serious and other, were documented at all study visits by the Medical Assistant on the adverse events case report form.
|
36.0%
9/25 • Adverse event data was collected at all study visits, for an average duration of 4 weeks (2 weeks on drug, and 2 weeks post treatment).
Adverse events, both serious and other, were documented at all study visits by the Medical Assistant on the adverse events case report form.
|
|
Nervous system disorders
Somnolence
|
26.9%
7/26 • Adverse event data was collected at all study visits, for an average duration of 4 weeks (2 weeks on drug, and 2 weeks post treatment).
Adverse events, both serious and other, were documented at all study visits by the Medical Assistant on the adverse events case report form.
|
12.0%
3/25 • Adverse event data was collected at all study visits, for an average duration of 4 weeks (2 weeks on drug, and 2 weeks post treatment).
Adverse events, both serious and other, were documented at all study visits by the Medical Assistant on the adverse events case report form.
|
|
Psychiatric disorders
Insomnia
|
7.7%
2/26 • Adverse event data was collected at all study visits, for an average duration of 4 weeks (2 weeks on drug, and 2 weeks post treatment).
Adverse events, both serious and other, were documented at all study visits by the Medical Assistant on the adverse events case report form.
|
8.0%
2/25 • Adverse event data was collected at all study visits, for an average duration of 4 weeks (2 weeks on drug, and 2 weeks post treatment).
Adverse events, both serious and other, were documented at all study visits by the Medical Assistant on the adverse events case report form.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place