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Accelerated Development of Additive Pharmacotherapy Treatment (ADAPT-2) for Methamphetamine Use Disorder (ADAPT-2)

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ClinicalTrials.gov Identifier: NCT03078075
Recruitment Status : Completed
First Posted : March 13, 2017
Last Update Posted : August 14, 2019
Sponsor:
Collaborators:
National Institute on Drug Abuse (NIDA)
The Emmes Company, LLC
Information provided by (Responsible Party):
Madhukar H. Trivedi, MD, University of Texas Southwestern Medical Center

Tracking Information
First Submitted Date  ICMJE March 2, 2017
First Posted Date  ICMJE March 13, 2017
Last Update Posted Date August 14, 2019
Actual Study Start Date  ICMJE May 5, 2017
Actual Primary Completion Date July 3, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 10, 2017)
Methamphetamine use [ Time Frame: Collected twice weekly for 12 weeks ]
Percent of urine drug screens negative for methamphetamine during the 12 weeks
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03078075 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 10, 2017)
Drug use other than methamphetamine [ Time Frame: Collected twice weekly for 12 weeks. ]
Percent of urine drug screens negative for drugs other than methamphetamine during the 12 weeks.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: March 10, 2017)
  • Depressive symptoms assessed using Patient Health Questionnaire-9 [ Time Frame: Collected once per week for 12 weeks. ]
    Patient Health Questionnaire-9
  • Quality of life assessed using 4-item quality of life self-report [ Time Frame: Collected once in Week 6 and once in Week 12 ]
    4-item quality of life self-report measure
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Accelerated Development of Additive Pharmacotherapy Treatment (ADAPT-2) for Methamphetamine Use Disorder
Official Title  ICMJE NIDA CTN Protocol 0068: Accelerated Development of Additive Pharmacotherapy Treatment (ADAPT-2) for Methamphetamine Use Disorder
Brief Summary This is a double-blind, placebo-controlled, randomized clinical trial evaluating the efficacy of extended-release naltrexone plus bupropion as a combination pharmacotherapy for methamphetamine use disorder. Participants will be randomly assigned to the active medication combination (AMC) group or matching placebo group and will receive medications over the course of 12 weeks. Follow-ups will occur in weeks 13 and 16.
Detailed Description There will be 400 adults with moderate or severe methamphetamine use disorder randomized into this multi-site study. Eligibility will be determined during a maximum 21 day screening period. After screening is completed and eligibility is confirmed, including successful administration of a naloxone challenge, participants will begin the 12 week medication phase of the trial. Participants will be randomized to either the 1) AMC arm and receive injections of extended release naltrexone (XR-NTX; as Vivitrol®) plus once-daily oral extended-release bupropion tablets (BUP-XL) or the 2) matching placebo (PLB) arm and receive injections of placebo (iPLB) plus once-daily oral placebo (oPLB) tablets. During the course of the study, participants may be switched to another arm, as determined by the a priori adaptive aspect of the study design. Participants appearing to respond well to their original treatment assignment will not be switched. Overall, approximately 50% of the participants will receive the AMC. Injections will be administered every three weeks, in weeks 1, 4, 7, and 10. Take-home oral study medication (BUP-XL or oPLB) will be dispensed weekly for dosing on non-clinic days. Participants will be asked to attend the clinic twice weekly for observed oral medication dosing, assessments, collection of urine samples, and once-weekly medical management. On non-clinic days, participants will participate in smartphone app-based medication adherence activities. Participants will be asked to complete assessments as indicated on the schedule of assessments. Following the 12 week medication phase, participants will complete a follow-up phase, including a medication taper and post-medication phase follow-up visits during weeks 13 and 16.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description:
During the study, participants may or may not be switched to another group due to the adaptive aspect of the study design. Participants appearing to respond well to their original treatment assignment will not be switched.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Methamphetamine Use Disorder
Intervention  ICMJE
  • Drug: Active Medication Combination (AMC)
    Naltrexone: 380 mg vial, 4 intramuscular injections administered every 3 weeks ; Bupropion: 450 mg oral dose daily
    Other Names:
    • Naltrexone: Vivitrol®
    • Bupropion: Wellbutrin XL®
  • Drug: Placebo (PLB)
    injectable matching placebo plus once-daily oral placebo tablets
    Other Names:
    • injectable matching placebo
    • once-daily oral matching placebo tablets
Study Arms  ICMJE
  • Experimental: Active Medication Combination (AMC)
    injectable extended release naltrexone plus once daily oral extended-release bupropion tablets
    Intervention: Drug: Active Medication Combination (AMC)
  • Placebo Comparator: Matched Placebo (PLB)
    injectable matching placebo plus once-daily oral placebo tablets
    Intervention: Drug: Placebo (PLB)
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: April 17, 2019)
403
Original Estimated Enrollment  ICMJE
 (submitted: March 10, 2017)
370
Actual Study Completion Date  ICMJE July 25, 2019
Actual Primary Completion Date July 3, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 18 to 65 years old;
  • Interested in reducing/stopping methamphetamine use;
  • Speak English;
  • Agree to use acceptable birth control (if applicable);
  • Be opioid-free at randomization;
  • Willing to comply with all study procedures and medication instructions;
  • Agree to use a cell phone (or similar study device) to take videos of medication dosing.

Exclusion Criteria:

  • Medical or psychiatric condition which would make participation unsafe;
  • Recently participated in a study of pharmacological or behavioral treatment for methamphetamine use disorder;
  • Recently taken an investigational drug;
  • Prescribed and taken naltrexone or bupropion ≤ 30 days from consent;
  • Current or planned extended absence during study period (e.g., jail, surgery, pending legal action);
  • 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 NCT03078075
Other Study ID Numbers  ICMJE CTN-0068
UG1DA020024 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Data from this study will be available to researchers on the website https://datashare.nida.nih.gov/ after the study is complete and the data is analyzed. This website will not include information that can identify individual study participants.The following information will be posted: Study protocol, reference to study publication of primary outcome, data sets (SAS and ASCII ), annotated case report forms, define file (also known as Data Dictionary), study-specific de-identification notes. Prior to downloading any study data, the user will be prompted to complete a registration agreement for data use. Users will have to register a name and valid e-mail address in order to download data and to accept their responsibility for using data in accordance with the NIDA Data Share Agreement.
Responsible Party Madhukar H. Trivedi, MD, University of Texas Southwestern Medical Center
Study Sponsor  ICMJE University of Texas Southwestern Medical Center
Collaborators  ICMJE
  • National Institute on Drug Abuse (NIDA)
  • The Emmes Company, LLC
Investigators  ICMJE
Principal Investigator: Madhukar Trivedi, MD University of Texas Southwestern Medical Center
PRS Account University of Texas Southwestern Medical Center
Verification Date August 2019

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