Trial record 15 of 30 for:    Open Studies | "Methamphetamine"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by University of California, Los Angeles
Sponsor:
Collaborators:
The EMMES Corporation
Information provided by (Responsible Party):
Walter Ling, University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT01982643
First received: November 4, 2013
Last updated: February 4, 2014
Last verified: February 2014
  Purpose

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: Endpoint Classification: Safety/Efficacy Study
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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 49
Study Start Date: November 2013
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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;
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01982643

Locations
United States, California
UCLA Integrated Substance Abuse Programs Recruiting
Los Angeles, California, United States, 90025
Contact: Jeffrey Annon    310-267-5333    jannon@ucla.edu   
Principal Investigator: Walter Ling, M.D.         
United States, Hawaii
University of Hawaii Recruiting
Honolulu, Hawaii, United States, 96813
Contact: Krista Bridges    808-691-8763    kristasb@hawaii.edu   
Principal Investigator: Linda Chang, M.D.         
United States, Texas
Nexus Recovery Center Recruiting
Dallas, Texas, United States, 75208
Contact: Erica Adkins    214-321-0156 ext 2800    dallasmethstudy@gmail.com   
Principal Investigator: Robrina Walker, Ph.D.         
Sponsors and Collaborators
Walter Ling
The EMMES Corporation
Investigators
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:
No publications provided

Responsible Party: Walter Ling, Professor of Psychiatry and Director, UCLA Integrated Substance Abuse Programs, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT01982643     History of Changes
Other Study ID Numbers: NIDA-CTN-0054, U10DA013045
Study First Received: November 4, 2013
Last Updated: February 4, 2014
Health Authority: United States: Data and Safety Monitoring Board
United States: Federal Government
United States: Institutional Review Board

Additional relevant MeSH terms:
Disease
Pathologic Processes
Methamphetamine
Bupropion
Naltrexone
Central Nervous System Stimulants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Dopamine Uptake Inhibitors
Narcotic Antagonists
Sensory System Agents
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs

ClinicalTrials.gov processed this record on September 30, 2014