Intermittent Naltrexone Among Polysubstance Users

Alcohol Clinical Trial

— Project iN  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01723384
• Other study ID #: 12-09809
• Secondary ID: R36DA035109-01
• Status: Completed
• Phase: Phase 2
• Start date: May 2013
• Est. completion date: November 2014

Study information

• Verified date: April 2019
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Alcohol
• Methamphetamine

Intervention

Drug:
• Intermittent Oral Naltrexone

• Placebo

Locations

Country	Name	City	State
United States	San Francisco Department of Public Health, Substance Use Research Unit	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of Retaining Participants in Trial	Proportion of persons retained by study arm.	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
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	2 month follow-up
Primary	Tolerability to Study Drug, as Measured by Adverse Events	Frequency of Adverse Events, by arm	2 months