Accelerated Development of Additive Pharmacotherapy Treatment for Methamphetamine Use Disorder
ADAPT
CTN-0054 Accelerated Development of Additive Pharmacotherapy Treatment (ADAPT) for Methamphetamine Use Disorder
2 other identifiers
interventional
49
1 country
3
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Nov 2013
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2013
CompletedFirst Submitted
Initial submission to the registry
November 4, 2013
CompletedFirst Posted
Study publicly available on registry
November 13, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2015
CompletedResults Posted
Study results publicly available
March 23, 2020
CompletedMarch 23, 2020
March 1, 2020
1.3 years
November 4, 2013
February 8, 2017
March 9, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Participants Categorized as "Responders"
Study "Responders" were defined as participants providing six MA-negative urine tests of eight administered in the evaluation period (the last four weeks of the active medication phase), including the last test collected in the final study week of the active medication phase.
Weeks 4-8
Study Arms (1)
naltrexone plus bupropion
EXPERIMENTALextended-release depot naltrexone (XR-NTX; as Vivitrol®)plus extended-release bupropion tablets (BRP; as Wellbutrin XL®)
Interventions
Participants will receive a monthly injection of extended-release depot naltrexone (XR-NTX; as Vivitrol®) plus once-daily bupropion extended-release tablets (BRP; as Wellbutrin XL®) for 8 weeks.
Eligibility Criteria
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;
- 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;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Walter Linglead
- National Institute on Drug Abuse (NIDA)collaborator
- The Emmes Company, LLCcollaborator
Study Sites (3)
UCLA Integrated Substance Abuse Programs
Los Angeles, California, 90025, United States
University of Hawaii
Honolulu, Hawaii, 96813, United States
Nexus Recovery Center
Dallas, Texas, 75208, United States
Related Publications (1)
Walker R, Hillhouse M, Perrochet B, Sparenborg S, Mooney L, Ling W. Medication Adherence Monitoring Using Smartphone Video Dosing in an Open-label Pilot Study of Monthly Naltrexone Plus Once-daily Bupropion for Methamphetamine Use Disorder: Feasibility and Acceptability. J Addict Med. 2019 Sep/Oct;13(5):372-378. doi: 10.1097/ADM.0000000000000509.
PMID: 30724759DERIVED
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Walter Ling, MD
- Organization
- UCLA Integrated Substance Abuse Programs
Study Officials
- PRINCIPAL INVESTIGATOR
Walter Ling, M.D.
UCLA Integrated Substance Abuse Programs
- PRINCIPAL INVESTIGATOR
Larissa Mooney, M.D.
UCLA Integrated Substance Abuse Programs
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor of Psychiatry and Director, UCLA Integrated Substance Abuse Programs
Study Record Dates
First Submitted
November 4, 2013
First Posted
November 13, 2013
Study Start
November 1, 2013
Primary Completion
February 1, 2015
Study Completion
February 1, 2015
Last Updated
March 23, 2020
Results First Posted
March 23, 2020
Record last verified: 2020-03