Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Methamphetamine Use Disorder
Intervention Drug: naltrexone plus bupropion
Enrollment 49
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Naltrexone Plus Bupropion
Hide Arm/Group Description

extended-release depot naltrexone (XR-NTX; as Vivitrol®)plus extended-release bupropion tablets (BRP; as Wellbutrin XL®)

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.

Period Title: Overall Study
Started 49
Completed 37
Not Completed 12
Arm/Group Title Naltrexone Plus Bupropion
Hide Arm/Group Description

extended-release depot naltrexone (XR-NTX; as Vivitrol®)plus extended-release bupropion tablets (BRP; as Wellbutrin XL®)

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.

Overall Number of Baseline Participants 49
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 49 participants
<=18 years
0
   0.0%
Between 18 and 65 years
48
  98.0%
>=65 years
1
   2.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 49 participants
39.9  (10.76)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 49 participants
Female
23
  46.9%
Male
26
  53.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 49 participants
49
1.Primary Outcome
Title Participants Categorized as "Responders"
Hide Description 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.
Time Frame Weeks 4-8
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Naltrexone Plus Bupropion
Hide Arm/Group Description:

extended-release depot naltrexone (XR-NTX; as Vivitrol®)plus extended-release bupropion tablets (BRP; as Wellbutrin XL®)

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.

Overall Number of Participants Analyzed 49
Measure Type: Count of Participants
Unit of Measure: Participants
11
  22.4%
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Naltrexone Plus Bupropion
Hide Arm/Group Description

extended-release depot naltrexone (XR-NTX; as Vivitrol®)plus extended-release bupropion tablets (BRP; as Wellbutrin XL®)

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.

All-Cause Mortality
Naltrexone Plus Bupropion
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Naltrexone Plus Bupropion
Affected / at Risk (%) # Events
Total   2/49 (4.08%)    
Nervous system disorders   
Seizure  1/49 (2.04%)  1
Surgical and medical procedures   
Inpatient admission to hospital or prolongation of existing hospitalization  1/49 (2.04%)  1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Naltrexone Plus Bupropion
Affected / at Risk (%) # Events
Total   45/49 (91.84%)    
Cardiac disorders   
Tachycardia  6/49 (12.24%) 
Eye disorders   
Vision blurred  4/49 (8.16%) 
Gastrointestinal disorders   
Nausea  28/49 (57.14%) 
Vomiting  11/49 (22.45%) 
Dry mouth  5/49 (10.20%) 
General disorders   
Fatigue  4/49 (8.16%) 
Irritability  3/49 (6.12%) 
Infections and infestations   
Nasopharyngitis  5/49 (10.20%) 
Gastroenteritis  5/49 (10.20%) 
Upper respiratory tract infection  5/49 (10.20%) 
Metabolism and nutrition disorders   
Decreased appetitite  3/49 (6.12%) 
Musculoskeletal and connective tissue disorders   
Back pain  4/49 (8.16%) 
Myalgia  3/49 (6.12%) 
Nervous system disorders   
Headache  14/49 (28.57%) 
Dizziness  3/49 (6.12%) 
Tremor  3/49 (6.12%) 
Somnolence  3/49 (6.12%) 
Psychiatric disorders   
Insomnia  6/49 (12.24%) 
Anxiety  6/49 (12.24%) 
Respiratory, thoracic and mediastinal disorders   
Couth  3/49 (6.12%) 
Skin and subcutaneous tissue disorders   
Rash  4/49 (8.16%) 
Vascular disorders   
Hyperthyrodism  5/49 (10.20%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Walter Ling, MD
Organization: UCLA Integrated Substance Abuse Programs
Phone: 310-267-5888
EMail: lwalter@ucla.edu
Layout table for additonal information
Responsible Party: Walter Ling, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT01982643    
Other Study ID Numbers: NIDA-CTN-0054
U10DA013045 ( U.S. NIH Grant/Contract )
First Submitted: November 4, 2013
First Posted: November 13, 2013
Results First Submitted: February 8, 2017
Results First Posted: March 23, 2020
Last Update Posted: March 23, 2020