Accelerated Development of Additive Pharmacotherapy Treatment for Methamphetamine Use Disorder

Completed · Phase 1/Phase 2

Conditions studied: Methamphetamine Use Disorder

In brief

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.

Key facts

Study ID

NCT01982643

Run by

Walter Ling

People needed

49

Starts

2013-11-01

Expected to finish

2015-02-01

Last updated by the study team

2020-03-23

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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;

You may not qualify if…

• 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;

Where it is running

• UCLA Integrated Substance Abuse Programs — Los Angeles, California, United States
• University of Hawaii — Honolulu, Hawaii, United States
• Nexus Recovery Center — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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