Trial Outcomes & Findings for Comparing Treatments for HIV-Infected Opioid and Alcohol Users in an Integrated Care Effectiveness Study (NCT NCT01908062)
NCT ID: NCT01908062
Last Updated: 2019-03-19
Results Overview
Successful induction onto XR-NTX or initiation of treatment as usual within 4 weeks of randomization.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
51 participants
Primary outcome timeframe
4 weeks
Results posted on
2019-03-19
Participant Flow
Participant milestones
| Measure |
Treatment as Usual
The current standard of care for treatment of opioid use disorders in HIV clinics is opioid agonist therapy. HIV-infected patients with alcohol use disorders are typically referred for residential, outpatient, and self-help groups.
Treatment As usual
|
Extended Release Naltrexone
Extended release naltrexone (XR-NTX), delivered by monthly injection. Dose: 380 mg. Frequency: One injection per month, for four months. Duration: 30 days.
Extended Release Naltrexone
|
|---|---|---|
|
Overall Study
STARTED
|
26
|
25
|
|
Overall Study
COMPLETED
|
24
|
22
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparing Treatments for HIV-Infected Opioid and Alcohol Users in an Integrated Care Effectiveness Study
Baseline characteristics by cohort
| Measure |
Treatment as Usual
n=26 Participants
The current standard of care for treatment of opioid use disorders in HIV clinics is opioid agonist therapy. HIV-infected patients with alcohol use disorders are typically referred for residential, outpatient, and self-help groups.
Treatment As usual
|
Extended Release Naltrexone
n=25 Participants
Extended release naltrexone (XR-NTX), delivered by monthly injection. Dose: 380 mg. Frequency: One injection per month, for four months. Duration: 30 days.
Extended Release Naltrexone
|
Total
n=51 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
45 years
STANDARD_DEVIATION 12 • n=5 Participants
|
47 years
STANDARD_DEVIATION 8.8 • n=7 Participants
|
46 years
STANDARD_DEVIATION 10 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
14 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 4 weeksSuccessful induction onto XR-NTX or initiation of treatment as usual within 4 weeks of randomization.
Outcome measures
| Measure |
Treatment as Usual
n=26 Participants
The current standard of care for treatment of opioid use disorders in HIV clinics is opioid agonist therapy. HIV-infected patients with alcohol use disorders are typically referred for residential, outpatient, and self-help groups.
Treatment As usual
|
Extended Release Naltrexone
n=25 Participants
Extended release naltrexone (XR-NTX), delivered by monthly injection. Dose: 380 mg. Frequency: One injection per month, for four months. Duration: 30 days.
Extended Release Naltrexone
|
|---|---|---|
|
Number of Participants With Successful Initiation of Treatment Within 4 Weeks of Randomization
|
25 Participants
|
17 Participants
|
PRIMARY outcome
Timeframe: 16 weeksPopulation: 24 TAU participants, and 17 XR-NTX participants initiated treatment in their respective arms. Treatment retention is calculated only for subjects who have been initiated onto treatment.
Number of participants who received the maximum possible expected doses of XR-NTX, or the full course of recommended pharmacotherapy treatment for treatment as usual (TAU) arm.
Outcome measures
| Measure |
Treatment as Usual
n=24 Participants
The current standard of care for treatment of opioid use disorders in HIV clinics is opioid agonist therapy. HIV-infected patients with alcohol use disorders are typically referred for residential, outpatient, and self-help groups.
Treatment As usual
|
Extended Release Naltrexone
n=17 Participants
Extended release naltrexone (XR-NTX), delivered by monthly injection. Dose: 380 mg. Frequency: One injection per month, for four months. Duration: 30 days.
Extended Release Naltrexone
|
|---|---|---|
|
Number of Participants Successfully Retained on Pharmacotherapy Treatment at 16 Weeks
|
12 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: 16 weeksPopulation: 23 TAU participants and 21 XR-NTX participants had a 16-week lab draw for HIV viral load testing.
Plasma HIV viral load of \< 200 copies/mL compared with screening
Outcome measures
| Measure |
Treatment as Usual
n=23 Participants
The current standard of care for treatment of opioid use disorders in HIV clinics is opioid agonist therapy. HIV-infected patients with alcohol use disorders are typically referred for residential, outpatient, and self-help groups.
Treatment As usual
|
Extended Release Naltrexone
n=21 Participants
Extended release naltrexone (XR-NTX), delivered by monthly injection. Dose: 380 mg. Frequency: One injection per month, for four months. Duration: 30 days.
Extended Release Naltrexone
|
|---|---|---|
|
HIV Viral Suppression at 16 Weeks
|
20 Participants
|
17 Participants
|
SECONDARY outcome
Timeframe: Baseline and 16 weeksPopulation: In both the TAU and XR-NTX groups, reporting results for participants who were retained at 16 weeks and completed necessary study assessments.
Change in 30 day opioid use by Addiction Severity Index (ASI)-lite self-report and Time-Line Follow Back in the final 30 days of the 16 week trial compared to screening.
Outcome measures
| Measure |
Treatment as Usual
n=12 Participants
The current standard of care for treatment of opioid use disorders in HIV clinics is opioid agonist therapy. HIV-infected patients with alcohol use disorders are typically referred for residential, outpatient, and self-help groups.
Treatment As usual
|
Extended Release Naltrexone
n=12 Participants
Extended release naltrexone (XR-NTX), delivered by monthly injection. Dose: 380 mg. Frequency: One injection per month, for four months. Duration: 30 days.
Extended Release Naltrexone
|
|---|---|---|
|
Mean Days of Opioid Use in Past 30 Days
Baseline mean days opioid use in past 30 days
|
17.3 days
Standard Deviation 13.14
|
20.3 days
Standard Deviation 12.29
|
|
Mean Days of Opioid Use in Past 30 Days
16 weeks mean days opioid use in past 30 days
|
4.1 days
Standard Deviation 5.43
|
7.7 days
Standard Deviation 11.32
|
SECONDARY outcome
Timeframe: Baseline and 16 weeksChange in the proportion of participants prescribed antiretroviral therapy (ART) within 16 weeks following randomization, compared to baseline.
Outcome measures
| Measure |
Treatment as Usual
n=26 Participants
The current standard of care for treatment of opioid use disorders in HIV clinics is opioid agonist therapy. HIV-infected patients with alcohol use disorders are typically referred for residential, outpatient, and self-help groups.
Treatment As usual
|
Extended Release Naltrexone
n=25 Participants
Extended release naltrexone (XR-NTX), delivered by monthly injection. Dose: 380 mg. Frequency: One injection per month, for four months. Duration: 30 days.
Extended Release Naltrexone
|
|---|---|---|
|
HIV Care Engagement
Prescribed ART at baseline
|
25 Participants
|
23 Participants
|
|
HIV Care Engagement
Prescribed ART at 16 weeks
|
26 Participants
|
24 Participants
|
SECONDARY outcome
Timeframe: Baseline and 16 weeksChange in liver enzymes between screening and Week 16. AST = Aspartate transaminase ALT = Alanine transaminase
Outcome measures
| Measure |
Treatment as Usual
n=26 Participants
The current standard of care for treatment of opioid use disorders in HIV clinics is opioid agonist therapy. HIV-infected patients with alcohol use disorders are typically referred for residential, outpatient, and self-help groups.
Treatment As usual
|
Extended Release Naltrexone
n=25 Participants
Extended release naltrexone (XR-NTX), delivered by monthly injection. Dose: 380 mg. Frequency: One injection per month, for four months. Duration: 30 days.
Extended Release Naltrexone
|
|---|---|---|
|
Participant Safety: Change in Liver Enzymes Between Baseline and Week 16
Mean AST at baseline
|
32.3 IU/L
Standard Deviation 19.4
|
36.8 IU/L
Standard Deviation 23.1
|
|
Participant Safety: Change in Liver Enzymes Between Baseline and Week 16
Mean AST at 16 weeks
|
32.2 IU/L
Standard Deviation 17.6
|
38.8 IU/L
Standard Deviation 27.6
|
|
Participant Safety: Change in Liver Enzymes Between Baseline and Week 16
Mean ALT at baseline
|
33.0 IU/L
Standard Deviation 24.5
|
35.0 IU/L
Standard Deviation 35.6
|
|
Participant Safety: Change in Liver Enzymes Between Baseline and Week 16
Mean ALT at 16 weeks
|
30.8 IU/L
Standard Deviation 18.1
|
40.1 IU/L
Standard Deviation 38.4
|
SECONDARY outcome
Timeframe: Baseline and 16 weeksPopulation: In both the TAU and XR-NTX groups, reporting results for participants who were retained at 16 weeks and completed necessary study assessments.
Outcome measures
| Measure |
Treatment as Usual
n=12 Participants
The current standard of care for treatment of opioid use disorders in HIV clinics is opioid agonist therapy. HIV-infected patients with alcohol use disorders are typically referred for residential, outpatient, and self-help groups.
Treatment As usual
|
Extended Release Naltrexone
n=12 Participants
Extended release naltrexone (XR-NTX), delivered by monthly injection. Dose: 380 mg. Frequency: One injection per month, for four months. Duration: 30 days.
Extended Release Naltrexone
|
|---|---|---|
|
Number of Participants With Urine Drug Screen (UDS) Positive for Opioids
Baseline UDS positive for opioids
|
9 Participants
|
9 Participants
|
|
Number of Participants With Urine Drug Screen (UDS) Positive for Opioids
16 weeks UDS positive for opioids
|
7 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Baseline and 16 weeksPopulation: In both the TAU and XR-NTX groups, reporting results for participants who were retained at 16 weeks and completed necessary study assessments.
Change in 30 day alcohol use by Addiction Severity Index (ASI)-lite self-report and Time-Line Follow Back in the final 30 days of the 16 week trial compared to screening.
Outcome measures
| Measure |
Treatment as Usual
n=14 Participants
The current standard of care for treatment of opioid use disorders in HIV clinics is opioid agonist therapy. HIV-infected patients with alcohol use disorders are typically referred for residential, outpatient, and self-help groups.
Treatment As usual
|
Extended Release Naltrexone
n=13 Participants
Extended release naltrexone (XR-NTX), delivered by monthly injection. Dose: 380 mg. Frequency: One injection per month, for four months. Duration: 30 days.
Extended Release Naltrexone
|
|---|---|---|
|
Mean Days of Alcohol Use in Past 30 Days
Baseline mean days alcohol use in past 30 days
|
15.6 days
Standard Deviation 9.95
|
12.5 days
Standard Deviation 11.02
|
|
Mean Days of Alcohol Use in Past 30 Days
16 weeks mean days alcohol use in past 30 days
|
5.7 days
Standard Deviation 8.40
|
2.8 days
Standard Deviation 3.05
|
SECONDARY outcome
Timeframe: Baseline and 16 weeksPopulation: In both the TAU and XR-NTX groups, reporting results for participants who were retained at 16 weeks and completed necessary study assessments.
Outcome measures
| Measure |
Treatment as Usual
n=14 Participants
The current standard of care for treatment of opioid use disorders in HIV clinics is opioid agonist therapy. HIV-infected patients with alcohol use disorders are typically referred for residential, outpatient, and self-help groups.
Treatment As usual
|
Extended Release Naltrexone
n=13 Participants
Extended release naltrexone (XR-NTX), delivered by monthly injection. Dose: 380 mg. Frequency: One injection per month, for four months. Duration: 30 days.
Extended Release Naltrexone
|
|---|---|---|
|
Number of Participants With Urine Ethyl Glucuronide (EtG) Positive for Alcohol
Baseline EtG positive for alcohol
|
7 Participants
|
6 Participants
|
|
Number of Participants With Urine Ethyl Glucuronide (EtG) Positive for Alcohol
16 weeks EtG positive for alcohol
|
4 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 16 weeksOutcome measures
| Measure |
Treatment as Usual
n=26 Participants
The current standard of care for treatment of opioid use disorders in HIV clinics is opioid agonist therapy. HIV-infected patients with alcohol use disorders are typically referred for residential, outpatient, and self-help groups.
Treatment As usual
|
Extended Release Naltrexone
n=25 Participants
Extended release naltrexone (XR-NTX), delivered by monthly injection. Dose: 380 mg. Frequency: One injection per month, for four months. Duration: 30 days.
Extended Release Naltrexone
|
|---|---|---|
|
Participant Safety: Any Fatal or Non-fatal Overdose Between Baseline and Week 16
Nonfatal opioid overdose
|
1 Participants
|
1 Participants
|
|
Participant Safety: Any Fatal or Non-fatal Overdose Between Baseline and Week 16
Fatal opioid overdose
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 16 weeksProportion of participants assigned to XR-NTX who develop precipitated opioid withdrawal.
Outcome measures
| Measure |
Treatment as Usual
n=25 Participants
The current standard of care for treatment of opioid use disorders in HIV clinics is opioid agonist therapy. HIV-infected patients with alcohol use disorders are typically referred for residential, outpatient, and self-help groups.
Treatment As usual
|
Extended Release Naltrexone
Extended release naltrexone (XR-NTX), delivered by monthly injection. Dose: 380 mg. Frequency: One injection per month, for four months. Duration: 30 days.
Extended Release Naltrexone
|
|---|---|---|
|
Participant Safety: Precipitated Withdrawal
|
0 Participants
|
—
|
Adverse Events
Treatment as Usual
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Extended Release Naltrexone
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment as Usual
n=26 participants at risk
The current standard of care for treatment of opioid use disorders in HIV clinics is opioid agonist therapy. HIV-infected patients with alcohol use disorders are typically referred for residential, outpatient, and self-help groups.
Treatment As usual
|
Extended Release Naltrexone
n=25 participants at risk
Extended release naltrexone (XR-NTX), delivered by monthly injection. Dose: 380 mg. Frequency: One injection per month, for four months. Duration: 30 days.
Extended Release Naltrexone
|
|---|---|---|
|
Psychiatric disorders
Suicidal Ideation
|
0.00%
0/26
|
4.0%
1/25 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Ankle Fracture
|
3.8%
1/26 • Number of events 1
|
0.00%
0/25
|
Other adverse events
| Measure |
Treatment as Usual
n=26 participants at risk
The current standard of care for treatment of opioid use disorders in HIV clinics is opioid agonist therapy. HIV-infected patients with alcohol use disorders are typically referred for residential, outpatient, and self-help groups.
Treatment As usual
|
Extended Release Naltrexone
n=25 participants at risk
Extended release naltrexone (XR-NTX), delivered by monthly injection. Dose: 380 mg. Frequency: One injection per month, for four months. Duration: 30 days.
Extended Release Naltrexone
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/26
|
8.0%
2/25
|
|
Nervous system disorders
Headache, Migraine
|
3.8%
1/26 • Number of events 26
|
8.0%
2/25 • Number of events 25
|
|
Gastrointestinal disorders
Nausea
|
15.4%
4/26
|
16.0%
4/25
|
|
Gastrointestinal disorders
Vomiting
|
3.8%
1/26
|
8.0%
2/25
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place