Trial Outcomes & Findings for A Novel Compound for Alcoholism Treatment: A Translational Strategy - Part II (NCT NCT02707055)
NCT ID: NCT02707055
Last Updated: 2022-03-16
Results Overview
Alcohol cue elicited craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
42 participants
Primary outcome timeframe
96 minutes
Results posted on
2022-03-16
Participant Flow
Of the 42 consented participants, 4 participants did not start the study due to screen failure, and 1 did not start the study due to organization issue.
Participant milestones
| Measure |
PF-05190457, Then Placebo
Participants with alcohol use disorder received PF-05190457 100 mg twice a day for a maximum of 14 days followed by a minimum of 2-day washout period, then placebo twice a day for a maximum of 14 days.
|
Placebo, Then PF-05190457
Participants with alcohol use disorder received placebo twice a day for a maximum of 14 days followed by a minimum of 2-day washout period then PF-05190457 100 mg twice a day for a maximum of 14 days.
|
|---|---|---|
|
Phase 1
STARTED
|
18
|
19
|
|
Phase 1
COMPLETED
|
17
|
16
|
|
Phase 1
NOT COMPLETED
|
1
|
3
|
|
Washout Period
STARTED
|
17
|
16
|
|
Washout Period
COMPLETED
|
17
|
16
|
|
Washout Period
NOT COMPLETED
|
0
|
0
|
|
Phase 2
STARTED
|
17
|
16
|
|
Phase 2
COMPLETED
|
16
|
14
|
|
Phase 2
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
PF-05190457, Then Placebo
Participants with alcohol use disorder received PF-05190457 100 mg twice a day for a maximum of 14 days followed by a minimum of 2-day washout period, then placebo twice a day for a maximum of 14 days.
|
Placebo, Then PF-05190457
Participants with alcohol use disorder received placebo twice a day for a maximum of 14 days followed by a minimum of 2-day washout period then PF-05190457 100 mg twice a day for a maximum of 14 days.
|
|---|---|---|
|
Phase 1
Withdrawal by Subject
|
1
|
2
|
|
Phase 1
Physician Decision
|
0
|
1
|
|
Phase 2
Adverse Event
|
1
|
2
|
Baseline Characteristics
A Novel Compound for Alcoholism Treatment: A Translational Strategy - Part II
Baseline characteristics by cohort
| Measure |
PF-05190457, Then Placebo
n=18 Participants
Participants with alcohol use disorder received PF-05190457 100 mg twice a day for a maximum of 14 days followed by a minimum of 2-day washout period, then placebo twice a day for a maximum of 14 days.
|
Placebo, Then PF-05190457
n=19 Participants
Participants with alcohol use disorder received placebo twice a day for a maximum of 14 days followed by a minimum of 2-day washout period then PF-05190457 100 mg twice a day for a maximum of 14 days.
|
Total
n=37 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
17 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
17 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 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
|
1 Participants
n=7 Participants
|
1 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
|
9 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
20 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
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 96 minutesPopulation: The analyses included those participants who completed the entire Cue Reactivity Procedure. 2 participants were not included in the final analysis - 1 for data quality issues and 1 for not completing the entire Cue Reactivity Procedure.
Alcohol cue elicited craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).
Outcome measures
| Measure |
PF-05190457
n=28 Participants
Participants with alcohol use disorder received PF-05190457 100 mg twice a day for a maximum of 14 days
|
Placebo
n=28 Participants
Participants with alcohol use disorder received placebo twice a day for a maximum of 14 days
|
|---|---|---|
|
Alcohol Cue-elicited Craving Assessed in a "Bar-like" Laboratory
|
15.52 units on a scale
Standard Error 1.19
|
15.88 units on a scale
Standard Error 1.095
|
SECONDARY outcome
Timeframe: 40 minutesPopulation: The analyses included those participants who completed the entire Virtual Reality Procedure. 1 participant was not included in the final analysis due to data quality issues.
Food choice was assessed by calculating the total of number of calories for a meal selected in a virtual buffet environment. Calories were adjusted for the size of items in the virtual reality environment.
Outcome measures
| Measure |
PF-05190457
n=29 Participants
Participants with alcohol use disorder received PF-05190457 100 mg twice a day for a maximum of 14 days
|
Placebo
n=29 Participants
Participants with alcohol use disorder received placebo twice a day for a maximum of 14 days
|
|---|---|---|
|
Food Choices in a "Virtual Buffet" Conducted in a Virtual Reality Context.
|
713.6 Adjusted calorie count
Standard Error 39.13
|
848.4 Adjusted calorie count
Standard Error 87.51
|
Adverse Events
PF-05190457
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
PF-05190457
n=37 participants at risk
Participants with alcohol use disorder received PF-05190457 100 mg twice a day for a maximum of 14 days
|
Placebo
n=37 participants at risk
Participants with alcohol use disorder received placebo twice a day for a maximum of 14 days
|
|---|---|---|
|
Eye disorders
Hordeolum
|
0.00%
0/37 • 35 days
Adverse events were monitored during clinical admission
|
2.7%
1/37 • Number of events 1 • 35 days
Adverse events were monitored during clinical admission
|
|
Gastrointestinal disorders
Abdominal pain
|
2.7%
1/37 • Number of events 1 • 35 days
Adverse events were monitored during clinical admission
|
2.7%
1/37 • Number of events 1 • 35 days
Adverse events were monitored during clinical admission
|
|
Gastrointestinal disorders
Constipation
|
2.7%
1/37 • Number of events 1 • 35 days
Adverse events were monitored during clinical admission
|
2.7%
1/37 • Number of events 1 • 35 days
Adverse events were monitored during clinical admission
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/37 • 35 days
Adverse events were monitored during clinical admission
|
2.7%
1/37 • Number of events 1 • 35 days
Adverse events were monitored during clinical admission
|
|
Gastrointestinal disorders
Flatulence
|
13.5%
5/37 • Number of events 7 • 35 days
Adverse events were monitored during clinical admission
|
16.2%
6/37 • Number of events 8 • 35 days
Adverse events were monitored during clinical admission
|
|
Gastrointestinal disorders
Nausea
|
2.7%
1/37 • Number of events 1 • 35 days
Adverse events were monitored during clinical admission
|
5.4%
2/37 • Number of events 2 • 35 days
Adverse events were monitored during clinical admission
|
|
Gastrointestinal disorders
Toothache
|
2.7%
1/37 • Number of events 1 • 35 days
Adverse events were monitored during clinical admission
|
0.00%
0/37 • 35 days
Adverse events were monitored during clinical admission
|
|
General disorders
Pain
|
2.7%
1/37 • Number of events 1 • 35 days
Adverse events were monitored during clinical admission
|
0.00%
0/37 • 35 days
Adverse events were monitored during clinical admission
|
|
Investigations
Blood creatinine increased
|
2.7%
1/37 • Number of events 1 • 35 days
Adverse events were monitored during clinical admission
|
0.00%
0/37 • 35 days
Adverse events were monitored during clinical admission
|
|
Investigations
Hepatic enzyme increased
|
5.4%
2/37 • Number of events 2 • 35 days
Adverse events were monitored during clinical admission
|
0.00%
0/37 • 35 days
Adverse events were monitored during clinical admission
|
|
Metabolism and nutrition disorders
Decreased appetite
|
2.7%
1/37 • Number of events 1 • 35 days
Adverse events were monitored during clinical admission
|
5.4%
2/37 • Number of events 2 • 35 days
Adverse events were monitored during clinical admission
|
|
Metabolism and nutrition disorders
Increased appetite
|
8.1%
3/37 • Number of events 3 • 35 days
Adverse events were monitored during clinical admission
|
10.8%
4/37 • Number of events 7 • 35 days
Adverse events were monitored during clinical admission
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.7%
1/37 • Number of events 1 • 35 days
Adverse events were monitored during clinical admission
|
2.7%
1/37 • Number of events 1 • 35 days
Adverse events were monitored during clinical admission
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
2.7%
1/37 • Number of events 1 • 35 days
Adverse events were monitored during clinical admission
|
0.00%
0/37 • 35 days
Adverse events were monitored during clinical admission
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
2.7%
1/37 • Number of events 1 • 35 days
Adverse events were monitored during clinical admission
|
0.00%
0/37 • 35 days
Adverse events were monitored during clinical admission
|
|
Nervous system disorders
Dizziness
|
2.7%
1/37 • Number of events 1 • 35 days
Adverse events were monitored during clinical admission
|
0.00%
0/37 • 35 days
Adverse events were monitored during clinical admission
|
|
Nervous system disorders
Headache
|
5.4%
2/37 • Number of events 3 • 35 days
Adverse events were monitored during clinical admission
|
13.5%
5/37 • Number of events 8 • 35 days
Adverse events were monitored during clinical admission
|
|
Nervous system disorders
Insomnia
|
8.1%
3/37 • Number of events 3 • 35 days
Adverse events were monitored during clinical admission
|
0.00%
0/37 • 35 days
Adverse events were monitored during clinical admission
|
|
Nervous system disorders
Lethargy
|
29.7%
11/37 • Number of events 20 • 35 days
Adverse events were monitored during clinical admission
|
24.3%
9/37 • Number of events 16 • 35 days
Adverse events were monitored during clinical admission
|
|
Nervous system disorders
Memory impairment
|
2.7%
1/37 • Number of events 1 • 35 days
Adverse events were monitored during clinical admission
|
2.7%
1/37 • Number of events 1 • 35 days
Adverse events were monitored during clinical admission
|
|
Psychiatric disorders
Anxiety
|
2.7%
1/37 • Number of events 1 • 35 days
Adverse events were monitored during clinical admission
|
0.00%
0/37 • 35 days
Adverse events were monitored during clinical admission
|
|
Psychiatric disorders
Depressed mood
|
2.7%
1/37 • Number of events 1 • 35 days
Adverse events were monitored during clinical admission
|
2.7%
1/37 • Number of events 1 • 35 days
Adverse events were monitored during clinical admission
|
|
Psychiatric disorders
Euphoric mood
|
2.7%
1/37 • Number of events 1 • 35 days
Adverse events were monitored during clinical admission
|
0.00%
0/37 • 35 days
Adverse events were monitored during clinical admission
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.7%
1/37 • Number of events 1 • 35 days
Adverse events were monitored during clinical admission
|
0.00%
0/37 • 35 days
Adverse events were monitored during clinical admission
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.7%
1/37 • Number of events 1 • 35 days
Adverse events were monitored during clinical admission
|
0.00%
0/37 • 35 days
Adverse events were monitored during clinical admission
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
5.4%
2/37 • Number of events 4 • 35 days
Adverse events were monitored during clinical admission
|
5.4%
2/37 • Number of events 2 • 35 days
Adverse events were monitored during clinical admission
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngitis
|
2.7%
1/37 • Number of events 1 • 35 days
Adverse events were monitored during clinical admission
|
2.7%
1/37 • Number of events 2 • 35 days
Adverse events were monitored during clinical admission
|
|
Skin and subcutaneous tissue disorders
Dandruff
|
0.00%
0/37 • 35 days
Adverse events were monitored during clinical admission
|
2.7%
1/37 • Number of events 1 • 35 days
Adverse events were monitored during clinical admission
|
Additional Information
Dr. Lorenzo Leggio, M.D., PhD
National Institute on Drug Abuse (NIDA); National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Phone: +1 443 740 2801
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place