Trial Outcomes & Findings for Reducing Heavy Drinking to Optimize HIV/AIDS Treatment and Prevention (NCT NCT01227044)
NCT ID: NCT01227044
Last Updated: 2019-03-21
Results Overview
The intent of this outcome is to compare the efficacy of NTX +MM/MC versus placebo +MM/MC on adherence to HAART. It is hypothesized that NTX +MM/MC will lead to improved adherence to HAART when compared to placebo + MM/MC.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
51 participants
Primary outcome timeframe
One year
Results posted on
2019-03-21
Participant Flow
Participant milestones
| Measure |
NTX + MM/MC
Naltrexone + Medical Management/Medication Coaching
Naltrexone: NTX arm will receive monthly extended release NTX doses at 380mg (4 mL), administered as an intramuscular gluteal injection at 4-week intervals.
|
Placebo + MM/MC
Placebo plus Medical Management/Medication Coaching
Placebo + Medication Management/Medication Coaching: Placebo + Medication Management/Medication Coaching
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
26
|
|
Overall Study
COMPLETED
|
19
|
17
|
|
Overall Study
NOT COMPLETED
|
6
|
9
|
Reasons for withdrawal
| Measure |
NTX + MM/MC
Naltrexone + Medical Management/Medication Coaching
Naltrexone: NTX arm will receive monthly extended release NTX doses at 380mg (4 mL), administered as an intramuscular gluteal injection at 4-week intervals.
|
Placebo + MM/MC
Placebo plus Medical Management/Medication Coaching
Placebo + Medication Management/Medication Coaching: Placebo + Medication Management/Medication Coaching
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
5
|
7
|
|
Overall Study
Discontinued Intervention
|
1
|
2
|
Baseline Characteristics
Reducing Heavy Drinking to Optimize HIV/AIDS Treatment and Prevention
Baseline characteristics by cohort
| Measure |
Placebo + MM/MC
n=26 Participants
Placebo plus Medical Management/Medication Coaching
Placebo + Medication Management/Medication Coaching: Placebo + Medication Management/Medication Coaching
|
NTX + MM/MC
n=25 Participants
Naltrexone + Medical Management/Medication Coaching
Naltrexone: NTX arm will receive monthly extended release NTX doses at 380mg (4 mL), administered as an intramuscular gluteal injection at 4-week intervals.
|
Total
n=51 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
51.2 years
STANDARD_DEVIATION 9.2 • n=93 Participants
|
51.2 years
STANDARD_DEVIATION 7.6 • n=4 Participants
|
51.2 years
STANDARD_DEVIATION 8.2 • n=27 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
15 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=93 Participants
|
17 Participants
n=4 Participants
|
36 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
White-non-Hispanic
|
2 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Black-non-Hispanic
|
19 Participants
n=93 Participants
|
17 Participants
n=4 Participants
|
36 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
3 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
26 participants
n=93 Participants
|
25 participants
n=4 Participants
|
51 participants
n=27 Participants
|
|
ART Adherence
|
.59 proportion of days adherent
STANDARD_DEVIATION .31 • n=93 Participants
|
.51 proportion of days adherent
STANDARD_DEVIATION .33 • n=4 Participants
|
.55 proportion of days adherent
STANDARD_DEVIATION .32 • n=27 Participants
|
|
Undetectable HIV Viral Load
|
16 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
26 Participants
n=27 Participants
|
|
CD4 count
|
513 cells/mm3
STANDARD_DEVIATION 423 • n=93 Participants
|
457 cells/mm3
STANDARD_DEVIATION 313 • n=4 Participants
|
487 cells/mm3
STANDARD_DEVIATION 374 • n=27 Participants
|
|
VACS Score
|
44 units on a scale
STANDARD_DEVIATION 26 • n=93 Participants
|
42 units on a scale
STANDARD_DEVIATION 26 • n=4 Participants
|
43 units on a scale
STANDARD_DEVIATION 26 • n=27 Participants
|
|
Heavy Drinking Days in past 30 Days
|
16.4 days
STANDARD_DEVIATION 8.4 • n=93 Participants
|
11.3 days
STANDARD_DEVIATION 8.4 • n=4 Participants
|
14.7 days
STANDARD_DEVIATION 9.8 • n=27 Participants
|
|
ANY Drinking Days in past 30 Days
|
19.2 days
STANDARD_DEVIATION 7.5 • n=93 Participants
|
14.8 days
STANDARD_DEVIATION 8.7 • n=4 Participants
|
17.9 days
STANDARD_DEVIATION 8.8 • n=27 Participants
|
|
Alcohol Abuse/Dependence
|
17 Participants
n=93 Participants
|
18 Participants
n=4 Participants
|
35 Participants
n=27 Participants
|
|
Drug Abuse/Dependence
|
19 Participants
n=93 Participants
|
20 Participants
n=4 Participants
|
39 Participants
n=27 Participants
|
|
Prior Alcohol or Drug Treatment
|
15 Participants
n=93 Participants
|
17 Participants
n=4 Participants
|
32 Participants
n=27 Participants
|
|
Prior Receipt for Medications to Help with Drinking
Overall
|
3 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
|
Prior Receipt for Medications to Help with Drinking
Naltrexone
|
2 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Prior Receipt for Medications to Help with Drinking
Acamprosate
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Prior Receipt for Medications to Help with Drinking
Disulfiram
|
1 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: One yearPopulation: data were analyzed intention to treat where all observations were included in the analyses, including those only measured at baseline.
The intent of this outcome is to compare the efficacy of NTX +MM/MC versus placebo +MM/MC on adherence to HAART. It is hypothesized that NTX +MM/MC will lead to improved adherence to HAART when compared to placebo + MM/MC.
Outcome measures
| Measure |
Placebo + MM/MC
n=26 Participants
Placebo plus Medical Management/Medication Coaching
Placebo + Medication Management/Medication Coaching: Placebo + Medication Management/Medication Coaching
|
NTX + MM/MC
n=25 Participants
Naltrexone + Medical Management/Medication Coaching
Naltrexone: NTX arm will receive monthly extended release NTX doses at 380mg (4 mL), administered as an intramuscular gluteal injection at 4-week intervals.
|
|---|---|---|
|
HAART Adherence
12 Weeks
|
7 Participants
|
4 Participants
|
|
HAART Adherence
24 Weeks
|
6 Participants
|
4 Participants
|
|
HAART Adherence
36 Weeks
|
8 Participants
|
4 Participants
|
|
HAART Adherence
52 Weeks
|
6 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: One yearPopulation: data were analyzed intention to treat where all observations were included in the analyses, including those only measured at baseline.
This outcome is intended to compare the efficacy of NTX +MM/MC versus placebo +MM/MC in reducing days of heavy drinking. It is hypothesized that NTX +MM/MC will lead to greater reductions in the number of days of heavy drinking when compared to placebo + MM/MC.
Outcome measures
| Measure |
Placebo + MM/MC
n=26 Participants
Placebo plus Medical Management/Medication Coaching
Placebo + Medication Management/Medication Coaching: Placebo + Medication Management/Medication Coaching
|
NTX + MM/MC
n=25 Participants
Naltrexone + Medical Management/Medication Coaching
Naltrexone: NTX arm will receive monthly extended release NTX doses at 380mg (4 mL), administered as an intramuscular gluteal injection at 4-week intervals.
|
|---|---|---|
|
Heavy Drinking Days
12 Weeks
|
8.4 days
Standard Deviation 6.8
|
1.7 days
Standard Deviation 4.7
|
|
Heavy Drinking Days
24 Weeks
|
5.4 days
Standard Deviation 8.4
|
0.1 days
Standard Deviation 5.3
|
|
Heavy Drinking Days
36 Weeks
|
4.2 days
Standard Deviation 5.0
|
0.5 days
Standard Deviation 2.0
|
|
Heavy Drinking Days
52 Weeks
|
5.8 days
Standard Deviation 8.3
|
0.3 days
Standard Deviation 4.9
|
Adverse Events
Placebo + MM/MC
Serious events: 3 serious events
Other events: 4 other events
Deaths: 0 deaths
NTX + MM/MC
Serious events: 6 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo + MM/MC
n=26 participants at risk
Placebo plus Medical Management/Medication Coaching
Placebo + Medication Management/Medication Coaching: Placebo + Medication Management/Medication Coaching
|
NTX + MM/MC
n=25 participants at risk
Naltrexone + Medical Management/Medication Coaching
Naltrexone: NTX arm will receive monthly extended release NTX doses at 380mg (4 mL), administered as an intramuscular gluteal injection at 4-week intervals.
|
|---|---|---|
|
Psychiatric disorders
Hallucination
|
0.00%
0/26 • Adverse events were collected up through the 1 year follow up period.
|
4.0%
1/25 • Number of events 1 • Adverse events were collected up through the 1 year follow up period.
|
|
General disorders
Intoxication
|
11.5%
3/26 • Number of events 6 • Adverse events were collected up through the 1 year follow up period.
|
0.00%
0/25 • Adverse events were collected up through the 1 year follow up period.
|
|
Psychiatric disorders
Suicidal Thoughts
|
3.8%
1/26 • Number of events 1 • Adverse events were collected up through the 1 year follow up period.
|
0.00%
0/25 • Adverse events were collected up through the 1 year follow up period.
|
|
Reproductive system and breast disorders
Testicular Inflammation
|
0.00%
0/26 • Adverse events were collected up through the 1 year follow up period.
|
4.0%
1/25 • Number of events 1 • Adverse events were collected up through the 1 year follow up period.
|
|
Nervous system disorders
Seizure
|
0.00%
0/26 • Adverse events were collected up through the 1 year follow up period.
|
4.0%
1/25 • Number of events 1 • Adverse events were collected up through the 1 year follow up period.
|
|
Cardiac disorders
Chest Pain
|
0.00%
0/26 • Adverse events were collected up through the 1 year follow up period.
|
8.0%
2/25 • Number of events 2 • Adverse events were collected up through the 1 year follow up period.
|
|
Nervous system disorders
Loss of Consciousness
|
0.00%
0/26 • Adverse events were collected up through the 1 year follow up period.
|
4.0%
1/25 • Number of events 2 • Adverse events were collected up through the 1 year follow up period.
|
|
Nervous system disorders
Hand Paralysis
|
0.00%
0/26 • Adverse events were collected up through the 1 year follow up period.
|
4.0%
1/25 • Number of events 1 • Adverse events were collected up through the 1 year follow up period.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/26 • Adverse events were collected up through the 1 year follow up period.
|
4.0%
1/25 • Number of events 2 • Adverse events were collected up through the 1 year follow up period.
|
|
Infections and infestations
Foot Infection
|
0.00%
0/26 • Adverse events were collected up through the 1 year follow up period.
|
4.0%
1/25 • Number of events 1 • Adverse events were collected up through the 1 year follow up period.
|
|
Injury, poisoning and procedural complications
Spinal Injury
|
0.00%
0/26 • Adverse events were collected up through the 1 year follow up period.
|
4.0%
1/25 • Number of events 1 • Adverse events were collected up through the 1 year follow up period.
|
|
Hepatobiliary disorders
Blood Clot
|
0.00%
0/26 • Adverse events were collected up through the 1 year follow up period.
|
4.0%
1/25 • Number of events 1 • Adverse events were collected up through the 1 year follow up period.
|
Other adverse events
| Measure |
Placebo + MM/MC
n=26 participants at risk
Placebo plus Medical Management/Medication Coaching
Placebo + Medication Management/Medication Coaching: Placebo + Medication Management/Medication Coaching
|
NTX + MM/MC
n=25 participants at risk
Naltrexone + Medical Management/Medication Coaching
Naltrexone: NTX arm will receive monthly extended release NTX doses at 380mg (4 mL), administered as an intramuscular gluteal injection at 4-week intervals.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Fall Related Injury
|
15.4%
4/26 • Number of events 4 • Adverse events were collected up through the 1 year follow up period.
|
12.0%
3/25 • Number of events 3 • Adverse events were collected up through the 1 year follow up period.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place