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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01982643
Recruitment Status : Completed
First Posted : November 13, 2013
Results First Posted : March 23, 2020
Last Update Posted : March 23, 2020
Sponsor:
Collaborators:
National Institute on Drug Abuse (NIDA)
The Emmes Company, LLC
Information provided by (Responsible Party):
Walter Ling, University of California, Los Angeles

Tracking Information
First Submitted Date  ICMJE November 4, 2013
First Posted Date  ICMJE November 13, 2013
Results First Submitted Date  ICMJE February 8, 2017
Results First Posted Date  ICMJE March 23, 2020
Last Update Posted Date March 23, 2020
Study Start Date  ICMJE November 2013
Actual Primary Completion Date February 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 9, 2020)
Participants Categorized as "Responders" [ Time Frame: Weeks 4-8 ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: November 5, 2013)
Number of methamphetamine negative urine test results [ Time Frame: in the final four weeks of the active medication phase ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Accelerated Development of Additive Pharmacotherapy Treatment for Methamphetamine Use Disorder
Official Title  ICMJE CTN-0054 Accelerated Development of Additive Pharmacotherapy Treatment (ADAPT) for Methamphetamine Use Disorder
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Methamphetamine Use Disorder
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: naltrexone plus bupropion
extended-release depot naltrexone (XR-NTX; as Vivitrol®)plus extended-release bupropion tablets (BRP; as Wellbutrin XL®)
Intervention: Drug: naltrexone plus bupropion
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 5, 2013)
49
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2015
Actual Primary Completion Date February 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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;
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01982643
Other Study ID Numbers  ICMJE NIDA-CTN-0054
U10DA013045 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Walter Ling, University of California, Los Angeles
Study Sponsor  ICMJE Walter Ling
Collaborators  ICMJE
  • National Institute on Drug Abuse (NIDA)
  • The Emmes Company, LLC
Investigators  ICMJE
Principal Investigator: Walter Ling, M.D. UCLA Integrated Substance Abuse Programs
Principal Investigator: Larissa Mooney, M.D. UCLA Integrated Substance Abuse Programs
PRS Account University of California, Los Angeles
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP