Alcohol, Methamphetamine
Conditions
Keywords
methamphetamine, alcohol, HIV, sexual behavior
Brief summary
Naltrexone, a µ-opioid receptor antagonist, is a promising agent for methamphetamine-using and binge-drinking men who have sex with men (MSM). Naltrexone has shown efficacy in reducing relapse to amphetamines and is FDA-approved for alcohol dependence. Oral naltrexone is inexpensive and has few toxicities but the standard daily regimen for naltrexone is problematic as patients forget to take the medication. Given the challenges in daily dosing, alternate regimen schedules have been proposed to increase efficacy and expand the population that may benefit from this pharmacologic agent. One approach is intermittent targeted administration of naltrexone, whereby individuals take the medication as-needed in anticipation of substance use or during periods of craving. Administration of naltrexone prior to exposure to amphetamines significantly attenuates craving and targeted naltrexone has shown efficacy in reducing heavy alcohol use. However, there have been no studies assessing intermittent targeted dosing of naltrexone among methamphetamine-using and binge-drinking MSM. Polysubstance use patterns are common among MSM, and studies among those who abuse more than one substance are urgently needed. The aims of this study are to determine whether targeted dosing of naltrexone is feasible, tolerable and acceptable among non-dependent methamphetamine-using and binge-drinking MSM.
Interventions
DRUGIntermittent Oral Naltrexone
DRUGPlacebo
Sponsors
National Institute on Drug Abuse (NIDA)
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
1. male gender or transgender male-to-female 2. self-reported anal sex with men in the prior six months while under the influence of meth and/or alcohol 3. self-reported meth use at least bi-weekly in the prior three months 4. at least weekly binge drinking (five or more drinks on a single drinking session) in the prior three months 4\) interested in reducing meth use and/or binge drinking 5) HIV-negative by rapid test or medical record of HIV infection 6) no current acute illnesses requiring prolonged medical care 7) no chronic illnesses that are likely to progress clinically during trial participation 8) able and willing to provide informed consent and adhere to visit schedule 9) age 18-70 years 10) baseline complete blood count (CBC), total protein, albumin, glucose, alkaline phosphatase, creatinine, blood urea nitrogen (BUN), and electrolytes without clinically significant abnormalities as determined by study clinician in conjunction with symptoms, physical exam, and medical history
Exclusion criteria
1. any psychiatric (e.g., depression with suicidal ideation) or medical condition that would preclude safe participation in the protocol 2. known allergy or previous adverse reaction to naltrexone 3. current use of or dependence on any opioids or a known medical condition which currently requires or may likely require opioid analgesics 4. opioid-positive urine test at enrollment 5. current cluster of differentiation 4 (CD4) count \< 200 cells/mm3 6. moderate or severe liver disease (aspartate aminotransferase, alanine aminotransferase, or total bilirubin \> 3 times upper limit of normal) 7. impaired renal function (creatinine clearance \< 60 ml/min) 8. currently participating in another research study 9. meth or alcohol dependence as determined by Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders (SCID) criteria 10. any condition that, in the principal investigator and/or study clinician's judgment interferes with safe participation or adherence to study procedures. 11. unwillingness to provide minimum locator for information 12. not having a cellular phone that can send or receive a text message 13. plans to leave the Bay Area during study follow-up 14. not comfortable speaking and reading English, enough to participate in a program in English
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of Retaining Participants in Trial | proportions eligible and enrolled assessed on ongoing basis throughout the study, proportion of visits completed assessed bi-weekly for each participant; overall retention assessed over 2 month follow-up for each participant | Proportion of persons retained by study arm. |
| Acceptability to Taking Medication | 2 month follow-up | Mean number of pills taken weekly, as determined by recorded openings from an electronic monitoring device for study medication pill dispensers |
| Tolerability to Study Drug, as Measured by Adverse Events | 2 months | Frequency of Adverse Events, by arm |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Naltrexone Intermittent oral naltrexone to be taken on an as-needed basis for 8 weeks.
Intermittent Oral Naltrexone | 15 |
| Placebo Intermittent oral placebo to be taken on an as-needed basis for 8 weeks
Placebo | 15 |
| Total | 30 |
Baseline characteristics
| Characteristic | Placebo | Naltrexone | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 15 Participants | 15 Participants | 30 Participants |
| Age, Continuous | 42.3 years STANDARD_DEVIATION 10 | 43.7 years STANDARD_DEVIATION 10 | 43 years STANDARD_DEVIATION 9.3 |
| Region of Enrollment United States | 15 participants | 15 participants | 30 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 15 Participants | 15 Participants | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 8 / 15 | 6 / 15 |
| serious Total, serious adverse events | 0 / 15 | 0 / 15 |
Outcome results
Primary
Acceptability to Taking Medication
Mean number of pills taken weekly, as determined by recorded openings from an electronic monitoring device for study medication pill dispensers
Time frame: 2 month follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Naltrexone | Acceptability to Taking Medication | 2.2 number of wisepill openings by week | Standard Deviation 1 |
| Placebo | Acceptability to Taking Medication | 1.9 number of wisepill openings by week | Standard Deviation 1 |
Primary
Feasibility of Retaining Participants in Trial
Proportion of persons retained by study arm.
Time frame: proportions eligible and enrolled assessed on ongoing basis throughout the study, proportion of visits completed assessed bi-weekly for each participant; overall retention assessed over 2 month follow-up for each participant
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Naltrexone | Feasibility of Retaining Participants in Trial | 100 percentage that completed study |
| Placebo | Feasibility of Retaining Participants in Trial | 86.7 percentage that completed study |
Primary
Tolerability to Study Drug, as Measured by Adverse Events
Frequency of Adverse Events, by arm
Time frame: 2 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Naltrexone | Tolerability to Study Drug, as Measured by Adverse Events | Nausea | 4 Count |
| Naltrexone | Tolerability to Study Drug, as Measured by Adverse Events | Headaches | 2 Count |
| Naltrexone | Tolerability to Study Drug, as Measured by Adverse Events | Upper respiratory tract infection | 2 Count |
| Placebo | Tolerability to Study Drug, as Measured by Adverse Events | Nausea | 2 Count |
| Placebo | Tolerability to Study Drug, as Measured by Adverse Events | Headaches | 1 Count |
| Placebo | Tolerability to Study Drug, as Measured by Adverse Events | Upper respiratory tract infection | 4 Count |