Accelerated Development of Additive Pharmacotherapy Treatment for Methamphetamine Use Disorder

Methamphetamine Use Disorder Clinical Trial

— ADAPT  

Official title:

CTN-0054 Accelerated Development of Additive Pharmacotherapy Treatment (ADAPT) for Methamphetamine Use Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01982643
• Other study ID #: NIDA-CTN-0054
• Secondary ID: U10DA013045
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: November 2013
• Est. completion date: February 2015

Study information

• Verified date: March 2020
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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;

Related Conditions & MeSH terms

• Disease
• Methamphetamine Use Disorder

Intervention

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.

Locations

Country	Name	City	State
United States	Nexus Recovery Center	Dallas	Texas
United States	University of Hawaii	Honolulu	Hawaii
United States	UCLA Integrated Substance Abuse Programs	Los Angeles	California

Sponsors (3)

Lead Sponsor	Collaborator
Walter Ling	National Institute on Drug Abuse (NIDA), The Emmes Company, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Participants Categorized as "Responders"	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.	Weeks 4-8

External Links

•   NIDA Clinical Trials Network Dissemination Library
•   NIH National Institute on Drug Abuse Clinical Trials Network
•   UCLA Integrated Substance Abuse Programs (ISAP)