Accelerated Development of Additive Pharmacotherapy Treatment for Methamphetamine Use Disorder

• Status: Completed
• Trial end date: 2015-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Walter Ling
• Collaborators: National Institute on Drug Abuse (NIDA); The Emmes Company, LLC; The EMMES Corporation
• Treatments: Bupropion; Methamphetamine; Naltrexone

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;