Naltrexone Hydrochloride for Methamphetamine Addiction

San Francisco Department of Public Health, San Francisco, CA
Methamphetamine AddictionNaltrexone Hydrochloride - Drug
Eligibility
18 - 70
Male
What conditions do you have?
Select

Study Summary

This trial will test the effectiveness of naltrexone, an as-needed medication, in reducing meth use among 54 MSM who use meth. The trial will last 12 weeks and will compare naltrexone to placebo.

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 2

Study Objectives

1 Primary · 1 Secondary · Reporting Duration: Every week from enrollment to the end of treatment at 12 weeks

Week 12
Mean change in serum drug levels (PrEP) or ART suppression rates from baseline to week 12 between Intermittent Oral Naltrexone vs placebo groups.
Mean change in sexual risk behaviors from baseline to week 12 between Intermittent Oral Naltrexone vs placebo groups.
Week 12
Mean Change in meth-positive urine tests from baseline to week 12 between Intermittent Oral Naltrexone vs. placebo groups

Trial Safety

Phase-Based Safety

2 of 3
This is further along than 68% of similar trials

Awards & Highlights

Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

2 Treatment Groups

Naltrexone with ecological momentary intervention
1 of 2
Placebo with ecological momentary intervention
1 of 2

Experimental Treatment

Non-Treatment Group

54 Total Participants · 2 Treatment Groups

Primary Treatment: Naltrexone Hydrochloride · Has Placebo Group · Phase 2

Naltrexone with ecological momentary interventionExperimental Group · 2 Interventions: Naltrexone Hydrochloride, Ecological Momentary Intervention · Intervention Types: Drug, Behavioral
Placebo with ecological momentary interventionPlaceboComparator Group · 2 Interventions: Placebo, Ecological Momentary Intervention · Intervention Types: Drug, Behavioral
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Naltrexone
FDA approved
Ecological Momentary Intervention
2020
N/A
~40

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: every week from enrollment to the end of treatment at 12 weeks

Who is running the clinical trial?

University of California, San FranciscoLead Sponsor
2,346 Previous Clinical Trials
11,782,658 Total Patients Enrolled
National Institute on Drug Abuse (NIDA)NIH
2,301 Previous Clinical Trials
2,022,363 Total Patients Enrolled
1 Trials studying Methamphetamine Addiction
8 Patients Enrolled for Methamphetamine Addiction
Glenn-Milo SantosLead Sponsor
2 Previous Clinical Trials
142 Total Patients Enrolled
Glenn-Milo Santos, PhD, MPHPrincipal InvestigatorUniversity of California, San Francisco
2 Previous Clinical Trials
142 Total Patients Enrolled

Eligibility Criteria

Age 18 - 70 · Male Participants · 4 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You use methamphetamine at least once a week according to what you have told us.
You are willing to try to stop using methamphetamine.
You were born as a male and identify as a male.
You have a problem with using methamphetamine, ranging from mild to severe.

Who else is applying?

What state do they live in?
Colorado50.0%
California50.0%
How old are they?
18 - 65100.0%
What portion of applicants met pre-screening criteria?
Did not meet criteria50.0%
Met criteria50.0%
What site did they apply to?
San Francisco Department of Public Health100.0%
Why did patients apply to this trial?
  • "I need help getting off meth"
How many prior treatments have patients received?
3+100.0%

Frequently Asked Questions

Has the FDA sanctioned Ecological Momentary Intervention for use in patient care?

"Due to its Phase 2 status, Ecological Momentary Intervention has been assigned a safety rating of 2 as there is reasonable evidence for the prevention of harm but no proof that it works." - Anonymous Online Contributor

Unverified Answer

Is it possible to join this medical trial?

"This clinical trial seeks 54 volunteers, ranging from 18 to 70 years of age, that are using methamphetamine. Other prerequisites include a willingness to reduce meth use; the absence of any acute medical issues necessitating prolonged care or chronic illnesses which might worsen during the study; and self-reported usage at least once per week." - Anonymous Online Contributor

Unverified Answer

What other investigations have employed Ecological Momentary Intervention as a tool?

"At present, 46 clinical trials related to Ecological Momentary Intervention are underway; 12 of which have advanced to Phase 3. These studies can be found in 161 different locations around the world, though a majority of them exist within New York City." - Anonymous Online Contributor

Unverified Answer

Is the research protocol currently recruiting participants?

"According to the data posted on clinicaltrials.gov, this research trial is actively seeking participants. The listing was first created on December 14th 2021 and the information has since been updated as recently as September 7th 2022." - Anonymous Online Contributor

Unverified Answer

What conditions are frequently managed through Ecological Momentary Intervention?

"Ecological Momentary Intervention is a viable treatment for managing weight, enhancing physical activity, and alleviating pain caused by chronic illness." - Anonymous Online Contributor

Unverified Answer

Does the cutoff age for entry into this clinical investigation rest below sixty years?

"The age range for prospective study participants is eighteen to seventy years old, according to the trial's acceptance criteria." - Anonymous Online Contributor

Unverified Answer

To what extent is this trial accommodating participants?

"Affirmative. This clinical trial, which was initially posted on December 14th 2021, is currently seeking participants. 54 subjects need to be recruited from 1 medical facility. The study's details were last modified on September 7th 2022 according to data hosted on clinicaltrials.gov." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.