Trial Outcomes & Findings for Intermittent Oral Naltrexone Enhanced With an Ecological Momentary Intervention for Methamphetamine-using MSM (NCT NCT04791969)
NCT ID: NCT04791969
Last Updated: 2025-10-27
Results Overview
As measured by the count of participants with meth-positive urine tests.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
60 participants
Primary outcome timeframe
Every week from week 1 to the end of treatment at 12 weeks
Results posted on
2025-10-27
Participant Flow
Additional participants were enrolled to account for higher than anticipated lost to follow-up during study. Enrollment sample approved by funder (National Institutes of Health), study Institutional Review Board and study data safety monitoring board.
Participant milestones
| Measure |
Naltrexone With Ecological Momentary Intervention
Naltrexone Hydrochloride, 50 mg., intermittent with ecological momentary assessment (EMA)
Naltrexone Hydrochloride: Intermittent Oral Naltrexone, 50 mg
Ecological Momentary Intervention: Receive ecological momentary intervention if ecological momentary assessment reports meth craving, stress, not taking study drug, or antecedents detected for "high risk" meth use.
|
Placebo With Ecological Momentary Intervention
Placebo, intermittent with ecological momentary assessment (EMA)
Placebo: Intermittent Oral Placebo
Ecological Momentary Intervention: Receive ecological momentary intervention if ecological momentary assessment reports meth craving, stress, not taking study drug, or antecedents detected for "high risk" meth use.
|
|---|---|---|
|
Overall Study
STARTED
|
40
|
20
|
|
Overall Study
COMPLETED
|
35
|
11
|
|
Overall Study
NOT COMPLETED
|
5
|
9
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Intermittent Oral Naltrexone Enhanced With an Ecological Momentary Intervention for Methamphetamine-using MSM
Baseline characteristics by cohort
| Measure |
Naltrexone With Ecological Momentary Intervention
n=40 Participants
Naltrexone Hydrochloride, 50 mg., intermittent with ecological momentary assessment (EMA)
Naltrexone Hydrochloride: Intermittent Oral Naltrexone, 50 mg
Ecological Momentary Intervention: Receive ecological momentary intervention if ecological momentary assessment reports meth craving, stress, not taking study drug, or antecedents detected for "high risk" meth use.
|
Placebo With Ecological Momentary Intervention
n=20 Participants
Placebo, intermittent with ecological momentary assessment (EMA)
Placebo: Intermittent Oral Placebo
Ecological Momentary Intervention: Receive ecological momentary intervention if ecological momentary assessment reports meth craving, stress, not taking study drug, or antecedents detected for "high risk" meth use.
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
43.58 years
STANDARD_DEVIATION 13.51 • n=5 Participants
|
44.65 years
STANDARD_DEVIATION 7.79 • n=7 Participants
|
43.93 years
STANDARD_DEVIATION 11.85 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
39 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
11 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
29 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
7 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
40 participants
n=5 Participants
|
20 participants
n=7 Participants
|
60 participants
n=5 Participants
|
|
Number of meth-using Male Partners
|
2.03 number of meth-using male partners
STANDARD_DEVIATION 1.29 • n=5 Participants
|
2.3 number of meth-using male partners
STANDARD_DEVIATION 1.08 • n=7 Participants
|
2.12 number of meth-using male partners
STANDARD_DEVIATION 1.22 • n=5 Participants
|
|
Meth positive urine sample
|
35 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
PrEP drug levels detected (PrEP Adherent) or Virally Suppressed (Antiretroviral treatment adherent)
|
7 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Every week from week 1 to the end of treatment at 12 weeksAs measured by the count of participants with meth-positive urine tests.
Outcome measures
| Measure |
Naltrexone With Ecological Momentary Intervention
n=40 Participants
Naltrexone Hydrochloride, 50 mg., intermittent with ecological momentary assessment (EMA)
Naltrexone Hydrochloride: Intermittent Oral Naltrexone, 50 mg
Ecological Momentary Intervention: Receive ecological momentary intervention if ecological momentary assessment reports meth craving, stress, not taking study drug, or antecedents detected for "high risk" meth use.
|
Placebo With Ecological Momentary Intervention
n=20 Participants
Placebo, intermittent with ecological momentary assessment (EMA)
Placebo: Intermittent Oral Placebo
Ecological Momentary Intervention: Receive ecological momentary intervention if ecological momentary assessment reports meth craving, stress, not taking study drug, or antecedents detected for "high risk" meth use.
|
|---|---|---|
|
Number of People With Meth-positive Urine Tests at Weekly Visits
Week 1
|
20 Participants
|
13 Participants
|
|
Number of People With Meth-positive Urine Tests at Weekly Visits
Week 2
|
23 Participants
|
9 Participants
|
|
Number of People With Meth-positive Urine Tests at Weekly Visits
Week 3
|
21 Participants
|
10 Participants
|
|
Number of People With Meth-positive Urine Tests at Weekly Visits
Week 4
|
25 Participants
|
10 Participants
|
|
Number of People With Meth-positive Urine Tests at Weekly Visits
Week 5
|
19 Participants
|
8 Participants
|
|
Number of People With Meth-positive Urine Tests at Weekly Visits
Week 6
|
16 Participants
|
8 Participants
|
|
Number of People With Meth-positive Urine Tests at Weekly Visits
Week 7
|
19 Participants
|
7 Participants
|
|
Number of People With Meth-positive Urine Tests at Weekly Visits
Week 8
|
19 Participants
|
5 Participants
|
|
Number of People With Meth-positive Urine Tests at Weekly Visits
Week 9
|
17 Participants
|
9 Participants
|
|
Number of People With Meth-positive Urine Tests at Weekly Visits
Week 10
|
19 Participants
|
9 Participants
|
|
Number of People With Meth-positive Urine Tests at Weekly Visits
Week 11
|
23 Participants
|
9 Participants
|
|
Number of People With Meth-positive Urine Tests at Weekly Visits
Week 12
|
27 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: Past month behavior, measured at the end of treatment at 12 weeksPopulation: Participants who completed sexual behavior questionnaire at final visit
As measured by the mean number of sexual partners with whom they used meth, in the prior month, at week 12
Outcome measures
| Measure |
Naltrexone With Ecological Momentary Intervention
n=35 Participants
Naltrexone Hydrochloride, 50 mg., intermittent with ecological momentary assessment (EMA)
Naltrexone Hydrochloride: Intermittent Oral Naltrexone, 50 mg
Ecological Momentary Intervention: Receive ecological momentary intervention if ecological momentary assessment reports meth craving, stress, not taking study drug, or antecedents detected for "high risk" meth use.
|
Placebo With Ecological Momentary Intervention
n=11 Participants
Placebo, intermittent with ecological momentary assessment (EMA)
Placebo: Intermittent Oral Placebo
Ecological Momentary Intervention: Receive ecological momentary intervention if ecological momentary assessment reports meth craving, stress, not taking study drug, or antecedents detected for "high risk" meth use.
|
|---|---|---|
|
Mean in Sexual Risk Behaviors at Week 12
|
1.23 number of meth-using male partners
Standard Deviation 1.19
|
1.0 number of meth-using male partners
Standard Deviation 1.10
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At the end of treatment at the 12-week visitPopulation: Participants who are HIV-negative and who provided samples for PrEP drug levels testing at final visit, or participants who are living with HIV and provided samples for HIV viral load testing
As measured by PrEP drug levels being detected in HIV negative participants (PrEP Adherent and viral suppression rates in HIV positive participants (Antiretroviral treatment adherent)
Outcome measures
| Measure |
Naltrexone With Ecological Momentary Intervention
n=21 Participants
Naltrexone Hydrochloride, 50 mg., intermittent with ecological momentary assessment (EMA)
Naltrexone Hydrochloride: Intermittent Oral Naltrexone, 50 mg
Ecological Momentary Intervention: Receive ecological momentary intervention if ecological momentary assessment reports meth craving, stress, not taking study drug, or antecedents detected for "high risk" meth use.
|
Placebo With Ecological Momentary Intervention
n=9 Participants
Placebo, intermittent with ecological momentary assessment (EMA)
Placebo: Intermittent Oral Placebo
Ecological Momentary Intervention: Receive ecological momentary intervention if ecological momentary assessment reports meth craving, stress, not taking study drug, or antecedents detected for "high risk" meth use.
|
|---|---|---|
|
Adherent to PrEP or to Antiretroviral Medication
|
15 Participants
|
7 Participants
|
Adverse Events
Naltrexone With Ecological Momentary Intervention
Serious events: 2 serious events
Other events: 7 other events
Deaths: 0 deaths
Placebo With Ecological Momentary Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Naltrexone With Ecological Momentary Intervention
n=40 participants at risk
Naltrexone Hydrochloride, 50 mg., intermittent with ecological momentary assessment (EMA)
Naltrexone Hydrochloride: Intermittent Oral Naltrexone, 50 mg
Ecological Momentary Intervention: Receive ecological momentary intervention if ecological momentary assessment reports meth craving, stress, not taking study drug, or antecedents detected for "high risk" meth use.
|
Placebo With Ecological Momentary Intervention
n=20 participants at risk
Placebo, intermittent with ecological momentary assessment (EMA)
Placebo: Intermittent Oral Placebo
Ecological Momentary Intervention: Receive ecological momentary intervention if ecological momentary assessment reports meth craving, stress, not taking study drug, or antecedents detected for "high risk" meth use.
|
|---|---|---|
|
Renal and urinary disorders
Post-obstructive renal failure
|
2.5%
1/40 • Number of events 1 • 12 weeks
Adverse events are assessed weekly by study clinician and also through the monthly safety lab tests
|
0.00%
0/20 • 12 weeks
Adverse events are assessed weekly by study clinician and also through the monthly safety lab tests
|
|
Musculoskeletal and connective tissue disorders
Hernia
|
2.5%
1/40 • Number of events 1 • 12 weeks
Adverse events are assessed weekly by study clinician and also through the monthly safety lab tests
|
0.00%
0/20 • 12 weeks
Adverse events are assessed weekly by study clinician and also through the monthly safety lab tests
|
Other adverse events
| Measure |
Naltrexone With Ecological Momentary Intervention
n=40 participants at risk
Naltrexone Hydrochloride, 50 mg., intermittent with ecological momentary assessment (EMA)
Naltrexone Hydrochloride: Intermittent Oral Naltrexone, 50 mg
Ecological Momentary Intervention: Receive ecological momentary intervention if ecological momentary assessment reports meth craving, stress, not taking study drug, or antecedents detected for "high risk" meth use.
|
Placebo With Ecological Momentary Intervention
n=20 participants at risk
Placebo, intermittent with ecological momentary assessment (EMA)
Placebo: Intermittent Oral Placebo
Ecological Momentary Intervention: Receive ecological momentary intervention if ecological momentary assessment reports meth craving, stress, not taking study drug, or antecedents detected for "high risk" meth use.
|
|---|---|---|
|
General disorders
Fatigue
|
5.0%
2/40 • Number of events 2 • 12 weeks
Adverse events are assessed weekly by study clinician and also through the monthly safety lab tests
|
0.00%
0/20 • 12 weeks
Adverse events are assessed weekly by study clinician and also through the monthly safety lab tests
|
|
Gastrointestinal disorders
Nausea
|
12.5%
5/40 • Number of events 5 • 12 weeks
Adverse events are assessed weekly by study clinician and also through the monthly safety lab tests
|
0.00%
0/20 • 12 weeks
Adverse events are assessed weekly by study clinician and also through the monthly safety lab tests
|
Additional Information
Glenn-Milo Santos
University of California San Francisco
Phone: (415) 476-1435
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place