Phase 2
N=49
Accelerated Development of Additive Pharmacotherapy Treatment for Methamphetamine Use Disorder
Methamphetamine Use Disorder
Bottom Line
View on ClinicalTrials.gov: NCT01982643 ↗Enrolled (actual)
49
Serious AEs
4.1%
Results posted
Mar 2020
Primary outcome: Primary: Participants Categorized as "Responders" — 11 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- naltrexone plus bupropion (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Walter Ling
- Primary completion
- Feb 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Participants Categorized as "Responders" |
11 | — |
Summary
The aim of this 2-stage, 3-site study is to investigate the effectiveness and safety of a combination of extended-release depot naltrexone plus extended-release bupropion as a potential pharmacotherapy for methamphetamine (MA) use disorder.
Eligibility Criteria
Inclusion Criteria
- Be 18 to 65 years of age;
- Be able to speak English sufficiently to understand the study procedures and provide written informed consent to participate in the study;
- Demonstrate understanding of study procedures by correctly answering all questions on the consent competency tool;
- Be interested in reducing or stopping methamphetamine use;
- Meet DSM-5 criteria for severe methamphetamine use disorder;
- Meet subjective and objective methamphetamine use criteria as defined by the protocol;
- Meet subjective and objective measures of being opioid-free prior to enrollment and medication induction per study medical clinician's determination (including passing a naloxone challenge);
- Agree to use study cellphone to record videos of take-home dosing for transfer to study team.
- If female of childbearing potential, agree to use acceptable birth control methods during participation in the study;
Exclusion Criteria
- Have known allergy or sensitivity to study medications;
- Have a medical history or condition that would make study participation difficult or unsafe;
- Have an acute psychiatric disorder or condition that would make study participation difficult or unsafe;
- Liver function test results greater than 5 times the upper limit of normal or other exclusionary clinical lab test values;
- Recent or ongoing treatment with medications that, in the judgment of the study medical clinician, could interact adversely with study drugs or interfere with study participation;
- Have a current pattern of alcohol, benzodiazepine, or other sedative-hypnotic use, as determined by the study medical clinician, which would preclude safe participation;
- Pending action or situation that might prevent remaining in the area for the duration of the study or prevent participation in study activities
- Be currently pregnant or breastfeeding;
Data sourced from ClinicalTrials.gov (NCT01982643). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.