Trial Outcomes & Findings for Aripiprazole Effects on Alcohol Drinking and Craving (NCT NCT01292057)
NCT ID: NCT01292057
Last Updated: 2017-08-08
Results Overview
"Natural" alcohol consumption period -- drinks per day consumed during the 6-day observation period
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
99 participants
Primary outcome timeframe
6-day observation period
Results posted on
2017-08-08
Participant Flow
Participant milestones
| Measure |
Aripiprazole
Medication
Aripiprazole: Aripiprazole(up to 15 mg/day) for 8 days
|
Sugar Pill
Placebo: Placebo to match active drug Aripiprazole for 8 days
|
|---|---|---|
|
Overall Study
STARTED
|
49
|
50
|
|
Overall Study
COMPLETED
|
47
|
48
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
Aripiprazole
Medication
Aripiprazole: Aripiprazole(up to 15 mg/day) for 8 days
|
Sugar Pill
Placebo: Placebo to match active drug Aripiprazole for 8 days
|
|---|---|---|
|
Overall Study
Protocol Violation
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
Baseline Characteristics
Aripiprazole Effects on Alcohol Drinking and Craving
Baseline characteristics by cohort
| Measure |
Aripiprazole
n=47 Participants
Medication
Aripiprazole: Aripiprazole(up to 15 mg/day) for 8 days
|
Sugar Pill
n=48 Participants
Placebo: Placebo to match active drug Aripiprazole for 8 days
|
Total
n=95 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
26.5 years
STANDARD_DEVIATION 5.6 • n=93 Participants
|
27.0 years
STANDARD_DEVIATION 5.3 • n=4 Participants
|
26.8 years
STANDARD_DEVIATION 5.4 • n=27 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
22 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=93 Participants
|
37 Participants
n=4 Participants
|
73 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
47 Participants
n=93 Participants
|
48 Participants
n=4 Participants
|
95 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 6-day observation period"Natural" alcohol consumption period -- drinks per day consumed during the 6-day observation period
Outcome measures
| Measure |
Aripiprazole
n=47 Participants
Medication
Aripiprazole: Aripiprazole(up to 15 mg/day) for 8 days
|
Sugar Pill
n=48 Participants
Placebo: Placebo to match active drug Aripiprazole for 8 days
|
|---|---|---|
|
Total Number of Drinks Per Day During Natural (Usual Environment) Conditions
|
5.8 standard drinks
Standard Error 0.4
|
6.4 standard drinks
Standard Error 0.4
|
PRIMARY outcome
Timeframe: 2 hours during the bar lab paradigmThis measure refers to a "bar lab" paradigm in which individuals received an initial "priming" drink of alcohol, targeted to produce a breath alcohol concentration (BrAC) of 30 mg%, and could then choose to consume up to 8 additional drinks, each targeted to produce a BrAC of 15 mg%, during the subsequent 2 hours. Thus, the total number of drinks consumed could range between 0 and 8.
Outcome measures
| Measure |
Aripiprazole
n=47 Participants
Medication
Aripiprazole: Aripiprazole(up to 15 mg/day) for 8 days
|
Sugar Pill
n=48 Participants
Placebo: Placebo to match active drug Aripiprazole for 8 days
|
|---|---|---|
|
Total Number of Drinks Consumed in Bar Lab
|
3.3 bar lab drinks
Standard Error 0.4
|
4.5 bar lab drinks
Standard Error 0.4
|
Adverse Events
Aripiprazole
Serious events: 0 serious events
Other events: 39 other events
Deaths: 0 deaths
Sugar Pill
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Aripiprazole
n=47 participants at risk
Medication
Aripiprazole: Aripiprazole(up to 15 mg/day) for 8 days
|
Sugar Pill
n=48 participants at risk
Placebo: Placebo to match active drug Aripiprazole for 8 days
|
|---|---|---|
|
Nervous system disorders
Trouble sleeping
|
29.8%
14/47 • 8 days
Adverse event defined as any symptom rated "moderate" or "severe" on a 21-item physical symptom checklist. Items from the checklist were: trouble sleeping, daytime sleepiness, nervousness, irritability, trouble concentrating, feeling depressed, abdominal pain, nausea/vomiting, constipation, joint pain, headache, dizziness, low energy, skin rash, ears ringing, vision blurry, itching, increased libido, decreased libido, difficulty reaching orgasm, and inability to reach orgasm.
|
18.8%
9/48 • 8 days
Adverse event defined as any symptom rated "moderate" or "severe" on a 21-item physical symptom checklist. Items from the checklist were: trouble sleeping, daytime sleepiness, nervousness, irritability, trouble concentrating, feeling depressed, abdominal pain, nausea/vomiting, constipation, joint pain, headache, dizziness, low energy, skin rash, ears ringing, vision blurry, itching, increased libido, decreased libido, difficulty reaching orgasm, and inability to reach orgasm.
|
|
Nervous system disorders
Daytime sleepiness
|
66.0%
31/47 • 8 days
Adverse event defined as any symptom rated "moderate" or "severe" on a 21-item physical symptom checklist. Items from the checklist were: trouble sleeping, daytime sleepiness, nervousness, irritability, trouble concentrating, feeling depressed, abdominal pain, nausea/vomiting, constipation, joint pain, headache, dizziness, low energy, skin rash, ears ringing, vision blurry, itching, increased libido, decreased libido, difficulty reaching orgasm, and inability to reach orgasm.
|
16.7%
8/48 • 8 days
Adverse event defined as any symptom rated "moderate" or "severe" on a 21-item physical symptom checklist. Items from the checklist were: trouble sleeping, daytime sleepiness, nervousness, irritability, trouble concentrating, feeling depressed, abdominal pain, nausea/vomiting, constipation, joint pain, headache, dizziness, low energy, skin rash, ears ringing, vision blurry, itching, increased libido, decreased libido, difficulty reaching orgasm, and inability to reach orgasm.
|
|
Nervous system disorders
Nervousness
|
8.5%
4/47 • 8 days
Adverse event defined as any symptom rated "moderate" or "severe" on a 21-item physical symptom checklist. Items from the checklist were: trouble sleeping, daytime sleepiness, nervousness, irritability, trouble concentrating, feeling depressed, abdominal pain, nausea/vomiting, constipation, joint pain, headache, dizziness, low energy, skin rash, ears ringing, vision blurry, itching, increased libido, decreased libido, difficulty reaching orgasm, and inability to reach orgasm.
|
2.1%
1/48 • 8 days
Adverse event defined as any symptom rated "moderate" or "severe" on a 21-item physical symptom checklist. Items from the checklist were: trouble sleeping, daytime sleepiness, nervousness, irritability, trouble concentrating, feeling depressed, abdominal pain, nausea/vomiting, constipation, joint pain, headache, dizziness, low energy, skin rash, ears ringing, vision blurry, itching, increased libido, decreased libido, difficulty reaching orgasm, and inability to reach orgasm.
|
|
Nervous system disorders
Irritability
|
17.0%
8/47 • 8 days
Adverse event defined as any symptom rated "moderate" or "severe" on a 21-item physical symptom checklist. Items from the checklist were: trouble sleeping, daytime sleepiness, nervousness, irritability, trouble concentrating, feeling depressed, abdominal pain, nausea/vomiting, constipation, joint pain, headache, dizziness, low energy, skin rash, ears ringing, vision blurry, itching, increased libido, decreased libido, difficulty reaching orgasm, and inability to reach orgasm.
|
12.5%
6/48 • 8 days
Adverse event defined as any symptom rated "moderate" or "severe" on a 21-item physical symptom checklist. Items from the checklist were: trouble sleeping, daytime sleepiness, nervousness, irritability, trouble concentrating, feeling depressed, abdominal pain, nausea/vomiting, constipation, joint pain, headache, dizziness, low energy, skin rash, ears ringing, vision blurry, itching, increased libido, decreased libido, difficulty reaching orgasm, and inability to reach orgasm.
|
|
Nervous system disorders
Trouble concentrating
|
29.8%
14/47 • 8 days
Adverse event defined as any symptom rated "moderate" or "severe" on a 21-item physical symptom checklist. Items from the checklist were: trouble sleeping, daytime sleepiness, nervousness, irritability, trouble concentrating, feeling depressed, abdominal pain, nausea/vomiting, constipation, joint pain, headache, dizziness, low energy, skin rash, ears ringing, vision blurry, itching, increased libido, decreased libido, difficulty reaching orgasm, and inability to reach orgasm.
|
6.2%
3/48 • 8 days
Adverse event defined as any symptom rated "moderate" or "severe" on a 21-item physical symptom checklist. Items from the checklist were: trouble sleeping, daytime sleepiness, nervousness, irritability, trouble concentrating, feeling depressed, abdominal pain, nausea/vomiting, constipation, joint pain, headache, dizziness, low energy, skin rash, ears ringing, vision blurry, itching, increased libido, decreased libido, difficulty reaching orgasm, and inability to reach orgasm.
|
|
Psychiatric disorders
Feeling depressed
|
6.4%
3/47 • 8 days
Adverse event defined as any symptom rated "moderate" or "severe" on a 21-item physical symptom checklist. Items from the checklist were: trouble sleeping, daytime sleepiness, nervousness, irritability, trouble concentrating, feeling depressed, abdominal pain, nausea/vomiting, constipation, joint pain, headache, dizziness, low energy, skin rash, ears ringing, vision blurry, itching, increased libido, decreased libido, difficulty reaching orgasm, and inability to reach orgasm.
|
4.2%
2/48 • 8 days
Adverse event defined as any symptom rated "moderate" or "severe" on a 21-item physical symptom checklist. Items from the checklist were: trouble sleeping, daytime sleepiness, nervousness, irritability, trouble concentrating, feeling depressed, abdominal pain, nausea/vomiting, constipation, joint pain, headache, dizziness, low energy, skin rash, ears ringing, vision blurry, itching, increased libido, decreased libido, difficulty reaching orgasm, and inability to reach orgasm.
|
|
Nervous system disorders
Headache
|
6.4%
3/47 • 8 days
Adverse event defined as any symptom rated "moderate" or "severe" on a 21-item physical symptom checklist. Items from the checklist were: trouble sleeping, daytime sleepiness, nervousness, irritability, trouble concentrating, feeling depressed, abdominal pain, nausea/vomiting, constipation, joint pain, headache, dizziness, low energy, skin rash, ears ringing, vision blurry, itching, increased libido, decreased libido, difficulty reaching orgasm, and inability to reach orgasm.
|
0.00%
0/48 • 8 days
Adverse event defined as any symptom rated "moderate" or "severe" on a 21-item physical symptom checklist. Items from the checklist were: trouble sleeping, daytime sleepiness, nervousness, irritability, trouble concentrating, feeling depressed, abdominal pain, nausea/vomiting, constipation, joint pain, headache, dizziness, low energy, skin rash, ears ringing, vision blurry, itching, increased libido, decreased libido, difficulty reaching orgasm, and inability to reach orgasm.
|
|
Nervous system disorders
Low energy
|
46.8%
22/47 • 8 days
Adverse event defined as any symptom rated "moderate" or "severe" on a 21-item physical symptom checklist. Items from the checklist were: trouble sleeping, daytime sleepiness, nervousness, irritability, trouble concentrating, feeling depressed, abdominal pain, nausea/vomiting, constipation, joint pain, headache, dizziness, low energy, skin rash, ears ringing, vision blurry, itching, increased libido, decreased libido, difficulty reaching orgasm, and inability to reach orgasm.
|
0.00%
0/48 • 8 days
Adverse event defined as any symptom rated "moderate" or "severe" on a 21-item physical symptom checklist. Items from the checklist were: trouble sleeping, daytime sleepiness, nervousness, irritability, trouble concentrating, feeling depressed, abdominal pain, nausea/vomiting, constipation, joint pain, headache, dizziness, low energy, skin rash, ears ringing, vision blurry, itching, increased libido, decreased libido, difficulty reaching orgasm, and inability to reach orgasm.
|
|
Reproductive system and breast disorders
Increased libido
|
6.4%
3/47 • 8 days
Adverse event defined as any symptom rated "moderate" or "severe" on a 21-item physical symptom checklist. Items from the checklist were: trouble sleeping, daytime sleepiness, nervousness, irritability, trouble concentrating, feeling depressed, abdominal pain, nausea/vomiting, constipation, joint pain, headache, dizziness, low energy, skin rash, ears ringing, vision blurry, itching, increased libido, decreased libido, difficulty reaching orgasm, and inability to reach orgasm.
|
4.2%
2/48 • 8 days
Adverse event defined as any symptom rated "moderate" or "severe" on a 21-item physical symptom checklist. Items from the checklist were: trouble sleeping, daytime sleepiness, nervousness, irritability, trouble concentrating, feeling depressed, abdominal pain, nausea/vomiting, constipation, joint pain, headache, dizziness, low energy, skin rash, ears ringing, vision blurry, itching, increased libido, decreased libido, difficulty reaching orgasm, and inability to reach orgasm.
|
|
Reproductive system and breast disorders
Decreased libido
|
6.4%
3/47 • 8 days
Adverse event defined as any symptom rated "moderate" or "severe" on a 21-item physical symptom checklist. Items from the checklist were: trouble sleeping, daytime sleepiness, nervousness, irritability, trouble concentrating, feeling depressed, abdominal pain, nausea/vomiting, constipation, joint pain, headache, dizziness, low energy, skin rash, ears ringing, vision blurry, itching, increased libido, decreased libido, difficulty reaching orgasm, and inability to reach orgasm.
|
0.00%
0/48 • 8 days
Adverse event defined as any symptom rated "moderate" or "severe" on a 21-item physical symptom checklist. Items from the checklist were: trouble sleeping, daytime sleepiness, nervousness, irritability, trouble concentrating, feeling depressed, abdominal pain, nausea/vomiting, constipation, joint pain, headache, dizziness, low energy, skin rash, ears ringing, vision blurry, itching, increased libido, decreased libido, difficulty reaching orgasm, and inability to reach orgasm.
|
Additional Information
Joseph Schacht, Ph.D.
Medical University of South Carolina
Phone: (843) 792-7497
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place