Trial Outcomes & Findings for Will Having Alcohol Treatment Improve Functioning? (NCT NCT01245647)

Results Overview

Average number of standard alcohol drinks per week, as measured by timeline follow-back. A drink typically contains about 0.6 grams of alcohol, and generally represents 1 12-oz beer, 1 5-oz glass of wine, or one shot of liquor.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

19 participants

Primary outcome timeframe

Month 4

Results posted on

2018-05-07

Participant Flow

We recruited participants from 3 sites in 3 cities: Washington, D.C., Chicago, and Jacksonville from December 2010 to February 2012. The last participant completed her 7-Month follow-up at October 2012.

Participant milestones

Participant milestones
Measure	Sugar Pill, 50mg, Once a Day for 4 Months. Placebo: placebo pills looked the same as the active comparator but were really sugar pills. Each study participant in this arm took a single pill once a day for 4 months.	Naltrexone, 50mg, Once a Day for 4 Months Naltrexone 50mg pills (single oral capsule): Each study participant in this arm took a single pill once a day for 4 months.
Overall Study STARTED	7	12
Overall Study COMPLETED	7	8
Overall Study NOT COMPLETED	0	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Will Having Alcohol Treatment Improve Functioning?

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sugar Pill, 50mg, Once a Day for 4 Months n=7 Participants Placebo: placebo pills looked the same as the active comparator but were really sugar pills. Each study participant in this arm took a single pill once a day for 4 months.	Naltrexone, 50mg, Once a Day for 4 Months n=12 Participants Naltrexone 50mg pills (single oral capsule): Each study participant in this arm took a single pill once a day for 4 months.	Total n=19 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=93 Participants	12 Participants n=4 Participants	19 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Continuous	50.2 years STANDARD_DEVIATION 9.3 • n=93 Participants	48.7 years STANDARD_DEVIATION 6.6 • n=4 Participants	49.3 years STANDARD_DEVIATION 7.5 • n=27 Participants
Sex: Female, Male Female	7 Participants n=93 Participants	12 Participants n=4 Participants	19 Participants n=27 Participants
Sex: Female, Male Male	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Region of Enrollment United States	7 participants n=93 Participants	12 participants n=4 Participants	19 participants n=27 Participants

PRIMARY outcome

Timeframe: Month 4

Population: All participants who provided data at the 4-month follow-up were included (n=15), which is 79% of persons who were randomized.

Average number of standard alcohol drinks per week, as measured by timeline follow-back. A drink typically contains about 0.6 grams of alcohol, and generally represents 1 12-oz beer, 1 5-oz glass of wine, or one shot of liquor.

Outcome measures

Outcome measures
Measure	Sugar Pill, 50mg, Once a Day for 4 Months. n=7 Participants Placebo: placebo pills looked the same as the active comparator but were really sugar pills. Each study participant in this arm took a single pill once a day for 4 months.	Naltrexone, 50mg, Once a Day for 4 Months n=8 Participants Naltrexone 50mg pills (single oral capsule): Each study participant in this arm took a single pill once a day for 4 months.
Number of Drinks Per Week	13.8 standard alcohol drinks per week Standard Deviation 12.4 • Interval 0.7 to 14.1	12.0 standard alcohol drinks per week Standard Deviation 16.5 • Interval -2.6 to 5.3

SECONDARY outcome

Timeframe: Month 4

Population: Only persons who reported current HIV medication use (n=13) were considered for this outcome, and we included data from the 12 persons who completed the 4-month assessment.

Medication adherence was measured on a visual analogue scale ranging from 0 - 100, and indicating what percentage of the persons' HIV medication was taken on schedule over the past week (self-report). A score of 95% or better was considered adherent, and we report the proportion of persons who were adherent in each group.

Outcome measures

Outcome measures
Measure	Sugar Pill, 50mg, Once a Day for 4 Months. n=6 Participants Placebo: placebo pills looked the same as the active comparator but were really sugar pills. Each study participant in this arm took a single pill once a day for 4 months.	Naltrexone, 50mg, Once a Day for 4 Months n=6 Participants Naltrexone 50mg pills (single oral capsule): Each study participant in this arm took a single pill once a day for 4 months.
HIV Medication Adherence (95% or Better)	50 percentage of participants	50 percentage of participants

SECONDARY outcome

Timeframe: 4 months

Risky sexual behavior was a dichotomous outcome for each participant at each time point, defined as having any non-condom-protected sex with a males who have an unknown/negative HIV status in the previous 30 days.

Outcome measures

Outcome measures
Measure	Sugar Pill, 50mg, Once a Day for 4 Months. n=7 Participants Placebo: placebo pills looked the same as the active comparator but were really sugar pills. Each study participant in this arm took a single pill once a day for 4 months.	Naltrexone, 50mg, Once a Day for 4 Months n=7 Participants Naltrexone 50mg pills (single oral capsule): Each study participant in this arm took a single pill once a day for 4 months.
Risky Sexual Behaviors	0 percentage of persons with risky sex	29 percentage of persons with risky sex

SECONDARY outcome

Timeframe: 4 months

Viral load was classified as either suppressed (HIV viral load \<50 copies/ml) or not suppressed (HIV viral load \>50 copies/ml). We report the proportion of participants who had a suppressed viral load (higher number is better)

Outcome measures

Outcome measures
Measure	Sugar Pill, 50mg, Once a Day for 4 Months. n=7 Participants Placebo: placebo pills looked the same as the active comparator but were really sugar pills. Each study participant in this arm took a single pill once a day for 4 months.	Naltrexone, 50mg, Once a Day for 4 Months n=8 Participants Naltrexone 50mg pills (single oral capsule): Each study participant in this arm took a single pill once a day for 4 months.
HIV Viral Load Suppressed	43 percentage of persons with suppressed VL	88 percentage of persons with suppressed VL

SECONDARY outcome

Timeframe: 4 months

Results from CD4 cell count result obtained either as lab specifically for this study, or from lab results that were collected at the same time point for a different study or clinical indication.

Outcome measures

Outcome measures
Measure	Sugar Pill, 50mg, Once a Day for 4 Months. n=6 Participants Placebo: placebo pills looked the same as the active comparator but were really sugar pills. Each study participant in this arm took a single pill once a day for 4 months.	Naltrexone, 50mg, Once a Day for 4 Months n=7 Participants Naltrexone 50mg pills (single oral capsule): Each study participant in this arm took a single pill once a day for 4 months.
CD4 Count (Mean)	669 CD4 count (cells/ml) Standard Deviation 478	761 CD4 count (cells/ml) Standard Deviation 207

Adverse Events

Sugar Pill, 50 mg Once a Day for 4 Months

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Naltrexone, 50mg Pill Once a Day for 4 Months

Serious events: 1 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Sugar Pill, 50 mg Once a Day for 4 Months n=7 participants at risk Placebo: placebo pills looked the same as the active comparator but were really sugar pills. Each study participant in this arm took a single pill once a day for 4 months.	Naltrexone, 50mg Pill Once a Day for 4 Months n=12 participants at risk Naltrexone 50mg pills (single oral capsule): Each study participant in this arm took a single pill once a day for 4 months.
Musculoskeletal and connective tissue disorders Muscle spasm/diarrhea/anxiety	0.00% 0/7	8.3% 1/12 • Number of events 1

Other adverse events

Other adverse events
Measure	Sugar Pill, 50 mg Once a Day for 4 Months n=7 participants at risk Placebo: placebo pills looked the same as the active comparator but were really sugar pills. Each study participant in this arm took a single pill once a day for 4 months.	Naltrexone, 50mg Pill Once a Day for 4 Months n=12 participants at risk Naltrexone 50mg pills (single oral capsule): Each study participant in this arm took a single pill once a day for 4 months.
General disorders Headache	0.00% 0/7	33.3% 4/12 • Number of events 4
Gastrointestinal disorders diarrhea/upset stomach	28.6% 2/7 • Number of events 2	33.3% 4/12 • Number of events 4
Metabolism and nutrition disorders Decreased appetite	28.6% 2/7 • Number of events 2	25.0% 3/12 • Number of events 3
Psychiatric disorders Anxiety	0.00% 0/7	25.0% 3/12 • Number of events 3
Nervous system disorders insomnia	14.3% 1/7 • Number of events 1	33.3% 4/12 • Number of events 4
Psychiatric disorders Depression	28.6% 2/7 • Number of events 2	25.0% 3/12 • Number of events 3
General disorders Sleepiness	14.3% 1/7 • Number of events 1	25.0% 3/12 • Number of events 3
Skin and subcutaneous tissue disorders Itching	14.3% 1/7 • Number of events 1	25.0% 3/12 • Number of events 3

Additional Information

Dr. Bob Cook

University of Florida

Phone: 352-273-5869

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place