MethamphetaminePhase 2Project iNNCT01723384
Intermittent Naltrexone Among Polysubstance Users
A Phase 2 study testing Intermittent Oral Naltrexone in people with Methamphetamine and Alcohol, run by University of California, San Francisco at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Methamphetamine, Alcohol
- What is being tested?
- Intermittent Oral Naltrexone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- May 2013to Nov 2014
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- male gender or transgender male-to-female
- self-reported anal sex with men in the prior six months while under the influence of meth and/or alcohol
- self-reported meth use at least bi-weekly in the prior three months
- 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
Who cannot join
- any psychiatric (e.g., depression with suicidal ideation) or medical condition that would preclude safe participation in the protocol
- known allergy or previous adverse reaction to naltrexone
- current use of or dependence on any opioids or a known medical condition which currently requires or may likely require opioid analgesics
- opioid-positive urine test at enrollment
- current cluster of differentiation 4 (CD4) count < 200 cells/mm3
- moderate or severe liver disease (aspartate aminotransferase, alanine aminotransferase, or total bilirubin > 3 times upper limit of normal)
Show all 14Show fewer
- impaired renal function (creatinine clearance < 60 ml/min)
- currently participating in another research study
- meth or alcohol dependence as determined by Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders (SCID) criteria
- any condition that, in the principal investigator and/or study clinician's judgment interferes with safe participation or adherence to study procedures.
- unwillingness to provide minimum locator for information
- not having a cellular phone that can send or receive a text message
- plans to leave the Bay Area during study follow-up
- not comfortable speaking and reading English, enough to participate in a program in English
Trial locations and contacts
1 site in 1 country.
United States1 site
San Francisco Department of Public Health, Substance Use Research Unit
San Francisco, California, 94102
About this study
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.
- Conditions
- Methamphetamine, Alcohol
- Being tested
- Intermittent Oral Naltrexone, Placebo
- Keywords
- methamphetamine, alcohol, HIV, sexual behavior
- Medical subject headings
- Sexual Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermittent Oral NaltrexoneDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Naltrexone | Active comparator | Intermittent oral naltrexone to be taken on an as-needed basis for 8 weeks. Receives: Drug: Intermittent Oral Naltrexone |
| Placebo | Placebo comparator | Intermittent oral placebo to be taken on an as-needed basis for 8 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Retaining Participants in Trial
Proportion of persons retained by study arm.
Measured: 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
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
Measured: 2 month follow-up
Tolerability to Study Drug, as Measured by Adverse Events
Frequency of Adverse Events, by arm
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2012 (estimated)
- Study startMay 2013
- Primary completionOct 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for MethamphetamineStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Glenn-Milo Santos, University of California, San Francisco
- Investigators
- Glenn-Milo Santos, PhD, Principal investigator, University of California, San FranciscoJason Euren, MA, Study director, San Francisco Department of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01723384
- Sponsor's protocol ID
- 12-09809
- Other IDs
- R36DA035109-01
- Acronym
- Project iN
- Status last verified
- Apr 2019
- First submitted
- 2 Nov 2012
- Last updated
- 23 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intermittent Naltrexone Among Polysubstance Users
- ClinicalTrials.gov ID
- NCT01723384
- Acronym / sponsor ID
- Project iN / 12-09809
- Conditions
- Methamphetamine, Alcohol
- Keywords
- methamphetamine, alcohol, HIV, sexual behavior
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- May 2013
- Primary completion
- Oct 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 7 Nov 2012 (estimated)
- Results
- Posted 12 Feb 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Naltrexone | Active comparator | Drug: Intermittent Oral NaltrexoneIntermittent oral naltrexone to be taken on an as-needed basis for 8 weeks. |
| Placebo | Placebo comparator | Drug: PlaceboIntermittent oral placebo to be taken on an as-needed basis for 8 weeks |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- male gender or transgender male-to-female
- self-reported anal sex with men in the prior six months while under the influence of meth and/or alcohol
- self-reported meth use at least bi-weekly in the prior three months
- 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
Key exclusion criteria (14 listed)
- any psychiatric (e.g., depression with suicidal ideation) or medical condition that would preclude safe participation in the protocol
- known allergy or previous adverse reaction to naltrexone
- current use of or dependence on any opioids or a known medical condition which currently requires or may likely require opioid analgesics
- opioid-positive urine test at enrollment
- current cluster of differentiation 4 (CD4) count < 200 cells/mm3
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intermittent Oral Naltrexone | Drug | Naltrexone |
| Placebo | Drug | Placebo |
Primary outcome
Feasibility of Retaining Participants in Trial
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
Proportion of persons retained by study arm.
Acceptability to Taking Medication
Time frame: 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
Time frame: 2 months
Frequency of Adverse Events, by arm
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Glenn-Milo Santos, PhD principal investigator
University of California, San Francisco
Jason Euren, MA study director
San Francisco Department of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Intermittent Oral Naltrexone in people with Methamphetamine and Alcohol, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of Retaining Participants in Trial (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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2019.