Say When: Targeting Heavy Alcohol Use With Naltrexone Among MSM
| Status: | Recruiting |
|---|---|
| Conditions: | HIV / AIDS, Psychiatric |
| Therapuetic Areas: | Immunology / Infectious Diseases, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 12/14/2018 |
| Start Date: | April 2015 |
| End Date: | August 2019 |
| Contact: | Jaclyn Hern, MPH |
| Email: | Jaclyn.hern@sfdph.org |
| Phone: | 415.437.6276 |
This is a double-blind, placebo-controlled trial of 120 binge-drinking MSM to 12 weeks of
naltrexone 50mg, to be taken in anticipation of heavy drinking. Ethnically and racially
diverse participants will be recruited using Respondent Driven Sampling as well as active
field recruitment. MSM will be seen weekly for alcohol-metabolite urine testing, study drug
dispensing, and brief counseling for alcohol use. Safety assessments and behavioral surveys
will be completed monthly.
naltrexone 50mg, to be taken in anticipation of heavy drinking. Ethnically and racially
diverse participants will be recruited using Respondent Driven Sampling as well as active
field recruitment. MSM will be seen weekly for alcohol-metabolite urine testing, study drug
dispensing, and brief counseling for alcohol use. Safety assessments and behavioral surveys
will be completed monthly.
Inclusion Criteria:
- (1) Male gender (2) self-reported anal sex with men in the prior three months while
under the influence of alcohol (3) at least one binge drinking (five or more drinks on
a single occasion) session per week in the prior three months; (4) interested in
reducing binge alcohol consumption; (5) HIV-negative by rapid antibody test or medical
record documentation of HIV infection (HIV positive participants); (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 CBC, total protein, albumin, glucose, alkaline phosphatase, creatinine, 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 study; (2) known allergy/previous adverse
reaction to naltrexone; (3) current use of/ dependence on any opioids or a known
medical condition which currently requires/may likely require opioid analgesics; (4)
opioid-positive urine at enrollment; (5) current CD4 count < 200 cells/mm3 (6)
moderate/severe liver disease (AST, ALT > 3 times upper limit of normal); (7) impaired
renal function (creatinine clearance < 50 ml/min); (8) currently participating in
another intervention research study with potential overlap; (9) alcohol dependence as
determined by SCID criteria (participants with non-dependent alcohol use
disorders/symptoms of alcohol abuse [per DSM-IV] are eligible) (10) any condition
that, in the principal investigator and/or study clinician's judgment interferes with
safe study participation or adherence to study procedures; (11) not having a
cell-phone that can send and receive text messages.
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