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Phase 2 N=49 Treatment

Accelerated Development of Additive Pharmacotherapy Treatment for Methamphetamine Use Disorder

Methamphetamine Use Disorder

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

OutcomeResultp-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;
View full record on ClinicalTrials.gov →

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.

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