Trial Outcomes & Findings for Better Than Study: Targeting Heavy Alcohol Use With Naltrexone Among Men Who Have Sex With Men (MSM) (NCT NCT02330419)
NCT ID: NCT02330419
Last Updated: 2025-04-20
Results Overview
This outcome measure determines the mean number of binge drinking days among participants randomized to targeted naltrexone and placebo arms. The Center for Disease Control (CDC) defines binge drinking as consuming 5 or more drinks on an occasion for men or 4 or more drinks on an occasion for women.
COMPLETED
PHASE2
120 participants
12 weeks
2025-04-20
Participant Flow
Participants were recruited via street outreach, recruitment flyers, sexual health clinics, needle exchanges, community organizations, bars, websites, and social media in San Francisco Bay Area.
Potential participants completed a brief telephone screen to assess initial eligibility and, if eligible, were scheduled for an in-person screening visit. All participants gave informed consent using University of California, San Francisco (UCSF) IRB-approved consent forms. Participants were evaluated for eligibility based on the inclusion criteria during the in-person screening visit.
Participant milestones
| Measure |
Placebo
Placebo (identical capsule as treatment arm) 50mg, taken as needed
|
Naltrexone
Naltrexone capsule, 50mg, taken as needed
|
|---|---|---|
|
Overall Study
STARTED
|
60
|
60
|
|
Overall Study
COMPLETED
|
57
|
53
|
|
Overall Study
NOT COMPLETED
|
3
|
7
|
Reasons for withdrawal
| Measure |
Placebo
Placebo (identical capsule as treatment arm) 50mg, taken as needed
|
Naltrexone
Naltrexone capsule, 50mg, taken as needed
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
7
|
Baseline Characteristics
Better Than Study: Targeting Heavy Alcohol Use With Naltrexone Among Men Who Have Sex With Men (MSM)
Baseline characteristics by cohort
| Measure |
Placebo
n=60 Participants
Placebo 50mg, as needed
Placebo
|
Naltrexone
n=60 Participants
Naltrexone 50mg, as needed
Naltrexone
|
Total
n=120 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
34 years
n=99 Participants
|
38 years
n=107 Participants
|
37 years
n=206 Participants
|
|
Sex/Gender, Customized
Gender Identity · Cis-gender male
|
59 Participants
n=99 Participants
|
60 Participants
n=107 Participants
|
119 Participants
n=206 Participants
|
|
Sex/Gender, Customized
Gender Identity · Transgender male (female to male)
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
32 Participants
n=99 Participants
|
33 Participants
n=107 Participants
|
65 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian
|
4 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black
|
5 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Latino
|
10 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Other
|
9 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
60 Participants
n=99 Participants
|
60 Participants
n=107 Participants
|
120 Participants
n=206 Participants
|
|
Education
high school or less
|
6 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Education
some college
|
19 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
36 Participants
n=206 Participants
|
|
Education
college or above
|
35 Participants
n=99 Participants
|
36 Participants
n=107 Participants
|
71 Participants
n=206 Participants
|
|
Income
under $20,000
|
13 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
29 Participants
n=206 Participants
|
|
Income
$20 - 39,999
|
17 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
29 Participants
n=206 Participants
|
|
Income
$40,000 and above
|
30 Participants
n=99 Participants
|
32 Participants
n=107 Participants
|
62 Participants
n=206 Participants
|
|
Employment
not employed
|
14 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
35 Participants
n=206 Participants
|
|
Employment
full-time
|
29 Participants
n=99 Participants
|
28 Participants
n=107 Participants
|
57 Participants
n=206 Participants
|
|
Employment
part-time
|
12 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
Employment
employed student
|
5 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Ever hospitalized for alcohol problem
No
|
54 Participants
n=99 Participants
|
50 Participants
n=107 Participants
|
104 Participants
n=206 Participants
|
|
Ever hospitalized for alcohol problem
Yes
|
6 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Ever received alcohol treatment
No
|
43 Participants
n=99 Participants
|
42 Participants
n=107 Participants
|
85 Participants
n=206 Participants
|
|
Ever received alcohol treatment
Yes
|
8 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
|
Ever received alcohol treatment
Missing
|
9 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Alcohol Craving Scale-Visual Analog
|
25 units on a scale
n=99 Participants
|
30 units on a scale
n=107 Participants
|
30 units on a scale
n=206 Participants
|
|
HIV Status
HIV-positive
|
17 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
31 Participants
n=206 Participants
|
|
HIV Status
HIV-negative
|
43 Participants
n=99 Participants
|
46 Participants
n=107 Participants
|
89 Participants
n=206 Participants
|
|
Has health insurance
No
|
6 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Has health insurance
Yes
|
54 Participants
n=99 Participants
|
55 Participants
n=107 Participants
|
109 Participants
n=206 Participants
|
|
Has regular health care provider
No
|
10 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Has regular health care provider
Yes
|
50 Participants
n=99 Participants
|
52 Participants
n=107 Participants
|
102 Participants
n=206 Participants
|
|
Center for Epidemiological Studies Depression scale (CES-D)
|
13 units on a scale
n=99 Participants
|
12 units on a scale
n=107 Participants
|
12 units on a scale
n=206 Participants
|
|
Alcohol Use Disorder Identification Test (AUDIT)
|
17 units on a scale
n=99 Participants
|
16 units on a scale
n=107 Participants
|
17 units on a scale
n=206 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: The binge drinking days analysis between targeted naltrexone and placebo arms is different from the participant flow chart. The overall number of participants is calculated from those participants that completed the ACASI survey at week 12.
This outcome measure determines the mean number of binge drinking days among participants randomized to targeted naltrexone and placebo arms. The Center for Disease Control (CDC) defines binge drinking as consuming 5 or more drinks on an occasion for men or 4 or more drinks on an occasion for women.
Outcome measures
| Measure |
Targeted Naltrexone/Placebo
n=108 Participants
Participants who were randomized to the Targeted Naltrexone and Placebo arms.
|
|---|---|
|
Binge Drinking Days Per Week
Naltrexone Arm
|
1.056 days per week
Standard Deviation 1.522
|
|
Binge Drinking Days Per Week
Placebo Arm
|
1.722 days per week
Standard Deviation 1.698
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: A total of 50 participants were analyzed in the targeted naltrexone arm and 52 participants were analyzed in the placebo arm.
This outcome measure determines the number of participants with positive ethyl glucuronide tests among non-dependent MSM who were randomized to targeted naltrexone and placebo arms. Ethyl glucuronide (EtG) is a non-volatile, water-soluble, stable, direct metabolite of ethanol that can be detected in urine for 48 hours or sometimes 72 hours after drinking if there is heavy drinking.
Outcome measures
| Measure |
Targeted Naltrexone/Placebo
n=102 Participants
Participants who were randomized to the Targeted Naltrexone and Placebo arms.
|
|---|---|
|
Positive Ethyl Glucuronide (EtG) Tests
Targeted Naltrexone
|
23 Participants
|
|
Positive Ethyl Glucuronide (EtG) Tests
Placebo
|
29 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: The overall number of participants analyzed for Male anal sex partners is based on those who completed the week 12 ACASI survey. This is different than the participant flow. There were 54 participants in each arm of the study.
This outcome measure determines the mean number of male anal sex partners among non-dependent MSM randomized to targeted naltrexone and placebo arms.
Outcome measures
| Measure |
Targeted Naltrexone/Placebo
n=108 Participants
Participants who were randomized to the Targeted Naltrexone and Placebo arms.
|
|---|---|
|
Male Anal Sex Partners
Targeted Naltrexone
|
1.06 sex partners
Standard Deviation 1.41
|
|
Male Anal Sex Partners
Placebo
|
1.98 sex partners
Standard Deviation 3.59
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: The overall number of participants analyzed for Unprotected anal sex partners while intoxicated with alcohol is based on the number of participants who completed the week 12 survey. This is different than the participant flow. There were 54 participants in the targeted naltrexone and the placebo arms.
This outcome measure determines the mean number of unprotected anal sex partners while intoxicated with alcohol among targeted naltrexone and placebo arms .
Outcome measures
| Measure |
Targeted Naltrexone/Placebo
n=108 Participants
Participants who were randomized to the Targeted Naltrexone and Placebo arms.
|
|---|---|
|
Unprotected Anal Sex Partners While Intoxicated With Alcohol
Targeted Naltrexone
|
0.96 partners
Standard Deviation 1.52
|
|
Unprotected Anal Sex Partners While Intoxicated With Alcohol
Placebo
|
0.56 partners
Standard Deviation 0.95
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: The overall number of participant analyzed for HIV-serodiscordant unprotected anal sex partners is based on the participants who completed the week 12 survey. This is different than the participant flow.
This outcome measure determines the mean number of HIV-serodiscordant unprotected anal sex partners among the targeted naltrexone and placebo arms.
Outcome measures
| Measure |
Targeted Naltrexone/Placebo
n=108 Participants
Participants who were randomized to the Targeted Naltrexone and Placebo arms.
|
|---|---|
|
HIV-serodiscordant Unprotected Anal Sex Partners
Targeted Naltrexone
|
0.28 partners
Standard Deviation 0.45
|
|
HIV-serodiscordant Unprotected Anal Sex Partners
Placebo
|
0.26 partners
Standard Deviation 0.44
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: The overall number of participants analyzed is based on those who completed the week 12 survey. This is different than the participant flow. There are 54 participants in each arm.
This outcome measure determines the mean number of unprotected anal sex events with serodiscordant partners
Outcome measures
| Measure |
Targeted Naltrexone/Placebo
n=108 Participants
Participants who were randomized to the Targeted Naltrexone and Placebo arms.
|
|---|---|
|
Unprotected Anal Sex Events With Serodiscordant Partners
Targeted Naltrexone
|
0.81 events
Standard Deviation 2.0
|
|
Unprotected Anal Sex Events With Serodiscordant Partners
Placebo
|
0.41 events
Standard Deviation 0.92
|
Adverse Events
Placebo
Naltrexone
Serious adverse events
| Measure |
Placebo
n=60 participants at risk
Placebo 50mg, as needed
Placebo
|
Naltrexone
n=60 participants at risk
Naltrexone 50mg, as needed
Naltrexone
|
|---|---|---|
|
Gastrointestinal disorders
bowel obstructions
|
1.7%
1/60 • Number of events 1 • 12 weeks
|
0.00%
0/60 • 12 weeks
|
|
Musculoskeletal and connective tissue disorders
soft-tissue infection
|
0.00%
0/60 • 12 weeks
|
1.7%
1/60 • Number of events 1 • 12 weeks
|
Other adverse events
| Measure |
Placebo
n=60 participants at risk
Placebo 50mg, as needed
Placebo
|
Naltrexone
n=60 participants at risk
Naltrexone 50mg, as needed
Naltrexone
|
|---|---|---|
|
Gastrointestinal disorders
nausea
|
6.7%
4/60 • Number of events 4 • 12 weeks
|
23.3%
14/60 • Number of events 14 • 12 weeks
|
|
Renal and urinary disorders
hyperglycemia
|
15.0%
9/60 • Number of events 9 • 12 weeks
|
13.3%
8/60 • Number of events 8 • 12 weeks
|
|
Vascular disorders
headache
|
3.3%
2/60 • Number of events 2 • 12 weeks
|
11.7%
7/60 • Number of events 7 • 12 weeks
|
|
Hepatobiliary disorders
increased ALT
|
5.0%
3/60 • Number of events 3 • 12 weeks
|
8.3%
5/60 • Number of events 5 • 12 weeks
|
|
Hepatobiliary disorders
increased AST
|
3.3%
2/60 • Number of events 2 • 12 weeks
|
10.0%
6/60 • Number of events 6 • 12 weeks
|
|
General disorders
rash
|
0.00%
0/60 • 12 weeks
|
5.0%
3/60 • Number of events 3 • 12 weeks
|
|
Metabolism and nutrition disorders
diarrhea
|
0.00%
0/60 • 12 weeks
|
5.0%
3/60 • Number of events 3 • 12 weeks
|
Additional Information
Glenn-Milo Santos, Associate Professor
Department of Community Health Systems, University of California at San Francisco
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place