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Accelerated Development of Additive Pharmacotherapy Treatment for Methamphetamine Use Disorder (ADAPT)

This study has been completed.
National Institute on Drug Abuse (NIDA)
The EMMES Corporation
Information provided by (Responsible Party):
Walter Ling, University of California, Los Angeles Identifier:
First received: November 4, 2013
Last updated: January 27, 2016
Last verified: January 2016
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.

Condition Intervention Phase
Methamphetamine Use Disorder
Drug: naltrexone plus bupropion
Phase 1
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: CTN-0054 Accelerated Development of Additive Pharmacotherapy Treatment (ADAPT) for Methamphetamine Use Disorder

Resource links provided by NLM:

Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • Number of methamphetamine negative urine test results [ Time Frame: in the final four weeks of the active medication phase ]

Enrollment: 49
Study Start Date: November 2013
Study Completion Date: February 2015
Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: naltrexone plus bupropion
extended-release depot naltrexone (XR-NTX; as Vivitrol®)plus extended-release bupropion tablets (BRP; as Wellbutrin XL®)
Drug: naltrexone plus bupropion
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.

Detailed Description:
Stage 1 will include 20 individuals with severe stimulant use disorder (methamphetamine type) enrolled across three study sites. Following a maximum 30-day screening period to establish eligibility, 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. Take-home oral study medication (BRP) will be dispensed weekly for dosing on non-clinic days. Participants will be asked to attend clinic twice weekly for observed BRP dosing, collection of urine samples, assessments, and medical management. Following the 8-week active medication phase, participants will complete a follow-up phase, including a medication taper and post-medication phase follow-up visit during Week 9. If Stage 1 data document success (see criteria below) in at least 3 "responder" study participants, Stage 2 will follow utilizing the same protocol as in Stage 1, to enroll an additional group of 29 participants. Using the same criteria of "responder" success, if the combined stages document success in at least 9 of 49 study participants, the combination medication will be considered to have shown sufficient potential to advance to a large-scale placebo-controlled trial.

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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;
  Contacts and Locations
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Please refer to this study by its identifier: NCT01982643

United States, California
UCLA Integrated Substance Abuse Programs
Los Angeles, California, United States, 90025
United States, Hawaii
University of Hawaii
Honolulu, Hawaii, United States, 96813
United States, Texas
Nexus Recovery Center
Dallas, Texas, United States, 75208
Sponsors and Collaborators
Walter Ling
National Institute on Drug Abuse (NIDA)
The EMMES Corporation
Principal Investigator: Walter Ling, M.D. UCLA Integrated Substance Abuse Programs
Principal Investigator: Larissa Mooney, M.D. UCLA Integrated Substance Abuse Programs
  More Information

Additional Information:
Responsible Party: Walter Ling, Professor of Psychiatry and Director, UCLA Integrated Substance Abuse Programs, University of California, Los Angeles Identifier: NCT01982643     History of Changes
Other Study ID Numbers: NIDA-CTN-0054
U10DA013045 ( US NIH Grant/Contract Award Number )
Study First Received: November 4, 2013
Last Updated: January 27, 2016

Additional relevant MeSH terms:
Pathologic Processes
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Central Nervous System Stimulants
Autonomic Agents
Adrenergic Agents
Adrenergic Uptake Inhibitors processed this record on April 26, 2017