Trial Outcomes & Findings for Clinical Trial to Reduce Drinking in Women With HIV (NCT NCT01625091)
NCT ID: NCT01625091
Last Updated: 2018-07-10
Results Overview
The primary statistical outcome for the trial is alcohol consumption at month 4 when the drug is stopped. This main outcome is a categorical variable of either quit hazardous drinking (defined as ≤7 drinks per week and \<4 drinks on any single day in the past 30 days), or did not quit (drinking exceeds the hazardous amount) .
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
194 participants
Primary outcome timeframe
Month 4
Results posted on
2018-07-10
Participant Flow
Participant milestones
| Measure |
Naltrexone
The participants took the drug naltrexone one single pill (50mg) each day for up to 4 months and then received final assessment at 7-months.
|
Placebo
The participants took an inert placebo one single pill each day for up to 4-months and then received final assessment at 7-months. Placebo is an inert pill that looks the same as naltrexone.
|
|---|---|---|
|
Intervention
STARTED
|
96
|
98
|
|
Intervention
2 Months
|
90
|
93
|
|
Intervention
4 Months
|
85
|
87
|
|
Intervention
COMPLETED
|
85
|
87
|
|
Intervention
NOT COMPLETED
|
11
|
11
|
|
Post-intervention
STARTED
|
85
|
87
|
|
Post-intervention
7 Months
|
81
|
85
|
|
Post-intervention
COMPLETED
|
81
|
85
|
|
Post-intervention
NOT COMPLETED
|
4
|
2
|
Reasons for withdrawal
| Measure |
Naltrexone
The participants took the drug naltrexone one single pill (50mg) each day for up to 4 months and then received final assessment at 7-months.
|
Placebo
The participants took an inert placebo one single pill each day for up to 4-months and then received final assessment at 7-months. Placebo is an inert pill that looks the same as naltrexone.
|
|---|---|---|
|
Intervention
Death
|
1
|
1
|
|
Intervention
Withdrawal by Subject
|
4
|
1
|
|
Intervention
Adverse Event
|
0
|
2
|
|
Intervention
Lost to Follow-up
|
4
|
4
|
|
Intervention
Study termination
|
2
|
3
|
|
Post-intervention
Death
|
0
|
1
|
|
Post-intervention
Lost to Follow-up
|
2
|
0
|
|
Post-intervention
Study termination
|
2
|
1
|
Baseline Characteristics
Clinical Trial to Reduce Drinking in Women With HIV
Baseline characteristics by cohort
| Measure |
Naltrexone
n=96 Participants
The participants took the drug naltrexone one single pill (50mg) each day for up to 4 months and then received final assessment at 7-months.
|
Placebo
n=98 Participants
The participants took an inert placebo one single pill each day for up to 4-months and then received final assessment at 7-months. Placebo is an inert pill that looks the same as naltrexone.
|
Total
n=194 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
47.7 years
STANDARD_DEVIATION 8.5 • n=5 Participants
|
48.9 years
STANDARD_DEVIATION 8.9 • n=7 Participants
|
48.3 years
STANDARD_DEVIATION 8.7 • n=5 Participants
|
|
Age, Customized
Age group · 18-39
|
16 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Age, Customized
Age group · 40-49
|
35 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
|
Age, Customized
Age group · 50-59
|
37 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
|
Age, Customized
Age group · ≥60
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
96 Participants
n=5 Participants
|
98 Participants
n=7 Participants
|
194 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Hispanic
|
11 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Not Hispanic, White
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Not Hispanic, Black
|
81 Participants
n=5 Participants
|
80 Participants
n=7 Participants
|
161 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Not Hispanic, Other
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Month 4The primary statistical outcome for the trial is alcohol consumption at month 4 when the drug is stopped. This main outcome is a categorical variable of either quit hazardous drinking (defined as ≤7 drinks per week and \<4 drinks on any single day in the past 30 days), or did not quit (drinking exceeds the hazardous amount) .
Outcome measures
| Measure |
Naltrexone
n=85 Participants
The participants took the drug naltrexone one single pill (50mg) each day for up to 4 months and then received final assessment at 7-months.
|
Placebo
n=87 Participants
The participants took an inert placebo one single pill each day for up to 4-months and then received final assessment at 7-months. Placebo is an inert pill that looks the same as naltrexone.
|
|---|---|---|
|
Number of Participants Who Quit Hazardous Drinking
|
44 Participants
|
39 Participants
|
SECONDARY outcome
Timeframe: Month 4In the past 30 days, total number of days with binge drinking which was defined as consuming ≥4 drinks on a single day (measured by Timeline Follow Back).
Outcome measures
| Measure |
Naltrexone
n=85 Participants
The participants took the drug naltrexone one single pill (50mg) each day for up to 4 months and then received final assessment at 7-months.
|
Placebo
n=87 Participants
The participants took an inert placebo one single pill each day for up to 4-months and then received final assessment at 7-months. Placebo is an inert pill that looks the same as naltrexone.
|
|---|---|---|
|
Number of Binge Drinking Days
|
0 Days
Interval 0.0 to 1.0
|
1 Days
Interval 0.0 to 2.0
|
SECONDARY outcome
Timeframe: 4 monthsThe Short Inventory of Problems (SIP-2R) seeks to measure the consequences of drinking in participants through questions related to guilt, reliability etc. The SIP-2R has 15 items asking how often the event happened during the past 3 months. Each item has a score from 0-3 (0=Never, 1=once or a few times, 2=once or twice a week, 3=daily or almost daily). The 15 questions from the SIP-2R are summed to create a total range of scores from 0-45.
Outcome measures
| Measure |
Naltrexone
n=85 Participants
The participants took the drug naltrexone one single pill (50mg) each day for up to 4 months and then received final assessment at 7-months.
|
Placebo
n=87 Participants
The participants took an inert placebo one single pill each day for up to 4-months and then received final assessment at 7-months. Placebo is an inert pill that looks the same as naltrexone.
|
|---|---|---|
|
Drinking Problems (SIP-2R Score)
|
7.2 units on a scale
Standard Deviation 9.9
|
6.7 units on a scale
Standard Deviation 8.4
|
SECONDARY outcome
Timeframe: 4 monthsSelf-reported scale of alcohol craving ranging from 0 (no craving) to 10 (strongest craving)
Outcome measures
| Measure |
Naltrexone
n=85 Participants
The participants took the drug naltrexone one single pill (50mg) each day for up to 4 months and then received final assessment at 7-months.
|
Placebo
n=87 Participants
The participants took an inert placebo one single pill each day for up to 4-months and then received final assessment at 7-months. Placebo is an inert pill that looks the same as naltrexone.
|
|---|---|---|
|
Craving for Alcohol
|
3.3 units on a scale
Standard Deviation 3.4
|
3.2 units on a scale
Standard Deviation 2.9
|
Adverse Events
Naltrexone
Serious events: 10 serious events
Other events: 77 other events
Deaths: 1 deaths
Placebo
Serious events: 6 serious events
Other events: 74 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Naltrexone
n=96 participants at risk
The participants took the drug naltrexone one single pill (50mg) each day for up to 4 months and then received final assessment at 7-months.
|
Placebo
n=98 participants at risk
The participants took an inert placebo one single pill each day for up to 4-months and then received final assessment at 7-months. Placebo is an inert pill that looks the same as naltrexone.
|
|---|---|---|
|
General disorders
Inpatient hospitalization
|
10.4%
10/96 • Number of events 10 • 7 months
|
6.1%
6/98 • Number of events 6 • 7 months
|
Other adverse events
| Measure |
Naltrexone
n=96 participants at risk
The participants took the drug naltrexone one single pill (50mg) each day for up to 4 months and then received final assessment at 7-months.
|
Placebo
n=98 participants at risk
The participants took an inert placebo one single pill each day for up to 4-months and then received final assessment at 7-months. Placebo is an inert pill that looks the same as naltrexone.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
36.5%
35/96 • 7 months
|
29.6%
29/98 • 7 months
|
|
Gastrointestinal disorders
Diarrhea
|
24.0%
23/96 • 7 months
|
27.6%
27/98 • 7 months
|
|
Nervous system disorders
Headache
|
29.2%
28/96 • 7 months
|
19.4%
19/98 • 7 months
|
|
General disorders
Fatigue
|
29.2%
28/96 • 7 months
|
18.4%
18/98 • 7 months
|
|
General disorders
Decreased appetite
|
21.9%
21/96 • 7 months
|
23.5%
23/98 • 7 months
|
|
Psychiatric disorders
Depression
|
28.1%
27/96 • 7 months
|
16.3%
16/98 • 7 months
|
|
General disorders
Sleepiness
|
25.0%
24/96 • 7 months
|
19.4%
19/98 • 7 months
|
|
General disorders
Dizziness
|
24.0%
23/96 • 7 months
|
14.3%
14/98 • 7 months
|
|
Skin and subcutaneous tissue disorders
Itchiness
|
15.6%
15/96 • 7 months
|
21.4%
21/98 • 7 months
|
|
Psychiatric disorders
Nervousness/Anxiety
|
16.7%
16/96 • 7 months
|
18.4%
18/98 • 7 months
|
|
General disorders
Abdominal pain
|
20.8%
20/96 • 7 months
|
13.3%
13/98 • 7 months
|
|
Gastrointestinal disorders
Vomiting
|
22.9%
22/96 • 7 months
|
8.2%
8/98 • 7 months
|
|
General disorders
Insomnia
|
15.6%
15/96 • 7 months
|
14.3%
14/98 • 7 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place