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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 : Recruiting
First Posted : March 13, 2017
Last Update Posted : August 2, 2018
Sponsor:
Collaborators:
National Institute on Drug Abuse (NIDA)
The EMMES Corporation
Information provided by (Responsible Party):
Madhukar H. Trivedi, University of Texas Southwestern Medical Center

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.

Condition or disease Intervention/treatment Phase
Methamphetamine Use Disorder Drug: Active Medication Combination (AMC) Drug: Placebo (PLB) Phase 3

Detailed Description:
There will be 370 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 : Interventional  (Clinical Trial)
Estimated Enrollment : 370 participants
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
Official Title: NIDA CTN Protocol 0068: Accelerated Development of Additive Pharmacotherapy Treatment (ADAPT-2) for Methamphetamine Use Disorder
Actual Study Start Date : May 5, 2017
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Methamphetamine

Arm Intervention/treatment
Experimental: Active Medication Combination (AMC)
injectable extended release naltrexone plus once daily oral extended-release bupropion tablets
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®

Placebo Comparator: Matched Placebo (PLB)
injectable matching placebo plus once-daily oral placebo tablets
Drug: Placebo (PLB)
injectable matching placebo plus once-daily oral placebo tablets
Other Names:
  • injectable matching placebo
  • once-daily oral matching placebo tablets




Primary Outcome Measures :
  1. Methamphetamine use [ Time Frame: Collected twice weekly for 12 weeks ]
    Percent of urine drug screens negative for methamphetamine during the 12 weeks


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. Depressive symptoms assessed using Patient Health Questionnaire-9 [ Time Frame: Collected once per week for 12 weeks. ]
    Patient Health Questionnaire-9

  2. 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



Information from the National Library of Medicine

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

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03078075


Contacts
Contact: Mora Kim, MPH 214-648-6213 adapt2@utsouthwestern.edu
Contact: Robrina Walker, PhD 214-645-6980 adapt2@utsouthwestern.edu

Locations
United States, California
University of California Los Angeles (UCLA) Center for Behavioral Addiction Medicine (CBAM) Recruiting
Los Angeles, California, United States, 90038
Contact: Sandy MacNicoll    310-709-1594    ctrsm@mednet.ucla.edu   
Principal Investigator: Steven Shoptaw, PhD         
Substance Use Research Unit (SURU) at the San Francisco Dept. of Public Health Recruiting
San Francisco, California, United States, 94102
Contact: Phillip Coffin, MD    415-437-6282    Phillip.Coffin@sfdph.org   
Principal Investigator: Phillip Coffin, MD         
United States, Minnesota
Hennepin County Medical Center- Berman Center for Research Recruiting
Minneapolis, Minnesota, United States, 55415
Contact: Nathan Tessum    612-873-6921    ntessum@bermancenter.org   
Principal Investigator: Gavin Bart, MD, PhD         
United States, New York
New York State Psychiatric Institute (NYSPI)- Substance Use Research Center (SURC) Recruiting
New York, New York, United States, 10032
Contact: Mark Rodriguez    646-774-8076    mark.rodriguez@nyspi.columbia.edu   
Principal Investigator: Edward Nunes, MD         
United States, Oregon
CODA, Inc. Recruiting
Portland, Oregon, United States, 97214
Contact: Katharina Wiest, PhD    503-309-3841    KatharinaWiest@codainc.org   
Principal Investigator: Katharina Wiest, PhD         
United States, South Carolina
Behavioral Health Services (BHS) of Pickens County Recruiting
Pickens, South Carolina, United States, 29671
Contact: Elizabeth Chapman    864-898-2992    echapman@bhspickens.com   
Principal Investigator: Susan Sonne, PharmD         
United States, Texas
University of Texas Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75235
Contact: Mark Vasquez    214-648-8810    Adapt2Dallas@UTSW.edu   
Contact: Angela Casey-Willingham    214-648-4690    angela.casey-willingham@utsouthwestern.edu   
Principal Investigator: Sidarth Wakhlu, MD         
University of Texas Health Science Center - Center for Neurobehavioral Research on Addiction (CNRA) Recruiting
Houston, Texas, United States, 77054
Contact: Jessica Vincent    713-486-2803    ms.CNRAresearch@uth.tmc.edu   
Principal Investigator: Joy Schmitz, PhD         
Sponsors and Collaborators
University of Texas Southwestern Medical Center
National Institute on Drug Abuse (NIDA)
The EMMES Corporation
Investigators
Principal Investigator: Madhukar Trivedi, MD University of Texas Southwestern Medical Center

Responsible Party: Madhukar H. Trivedi, Professor, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT03078075     History of Changes
Other Study ID Numbers: CTN-0068
UG1DA020024 ( U.S. NIH Grant/Contract )
First Posted: March 13, 2017    Key Record Dates
Last Update Posted: August 2, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
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.

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

Keywords provided by Madhukar H. Trivedi, University of Texas Southwestern Medical Center:
Methamphetamine
Methamphetamine Use Disorder
Naltrexone
Bupropion
Vivitrol®

Additional relevant MeSH terms:
Disease
Pathologic Processes
Naltrexone
Methamphetamine
Bupropion
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
Sympathomimetics
Autonomic Agents
Adrenergic Agents
Adrenergic Uptake Inhibitors