Trial Outcomes & Findings for Accelerated Development of Additive Pharmacotherapy Treatment for Methamphetamine Use Disorder (NCT NCT01982643)
NCT ID: NCT01982643
Last Updated: 2020-03-23
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
49 participants
Primary outcome timeframe
Weeks 4-8
Results posted on
2020-03-23
Participant Flow
Participant milestones
| Measure |
Naltrexone Plus Bupropion
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 Study
STARTED
|
49
|
|
Overall Study
COMPLETED
|
37
|
|
Overall Study
NOT COMPLETED
|
12
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Accelerated Development of Additive Pharmacotherapy Treatment for Methamphetamine Use Disorder
Baseline characteristics by cohort
| Measure |
Naltrexone Plus Bupropion
n=49 Participants
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.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
48 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
|
Age, Continuous
|
39.9 years
STANDARD_DEVIATION 10.76 • n=5 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
49 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Weeks 4-8Study "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.
Outcome measures
| Measure |
Naltrexone Plus Bupropion
n=49 Participants
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.
|
|---|---|
|
Participants Categorized as "Responders"
|
11 Participants
|
Adverse Events
Naltrexone Plus Bupropion
Serious events: 2 serious events
Other events: 45 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Naltrexone Plus Bupropion
n=49 participants at risk
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.
|
|---|---|
|
Surgical and medical procedures
Inpatient admission to hospital or prolongation of existing hospitalization
|
2.0%
1/49 • Number of events 1
|
|
Nervous system disorders
Seizure
|
2.0%
1/49 • Number of events 1
|
Other adverse events
| Measure |
Naltrexone Plus Bupropion
n=49 participants at risk
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.
|
|---|---|
|
Gastrointestinal disorders
Nausea
|
57.1%
28/49
|
|
Gastrointestinal disorders
Vomiting
|
22.4%
11/49
|
|
Gastrointestinal disorders
Dry mouth
|
10.2%
5/49
|
|
Nervous system disorders
Headache
|
28.6%
14/49
|
|
Nervous system disorders
Dizziness
|
6.1%
3/49
|
|
Nervous system disorders
Tremor
|
6.1%
3/49
|
|
Nervous system disorders
Somnolence
|
6.1%
3/49
|
|
Infections and infestations
Nasopharyngitis
|
10.2%
5/49
|
|
Infections and infestations
Gastroenteritis
|
10.2%
5/49
|
|
Infections and infestations
Upper respiratory tract infection
|
10.2%
5/49
|
|
Psychiatric disorders
Insomnia
|
12.2%
6/49
|
|
Psychiatric disorders
Anxiety
|
12.2%
6/49
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.2%
4/49
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.1%
3/49
|
|
General disorders
Fatigue
|
8.2%
4/49
|
|
General disorders
Irritability
|
6.1%
3/49
|
|
Vascular disorders
Hyperthyrodism
|
10.2%
5/49
|
|
Skin and subcutaneous tissue disorders
Rash
|
8.2%
4/49
|
|
Respiratory, thoracic and mediastinal disorders
Couth
|
6.1%
3/49
|
|
Cardiac disorders
Tachycardia
|
12.2%
6/49
|
|
Eye disorders
Vision blurred
|
8.2%
4/49
|
|
Metabolism and nutrition disorders
Decreased appetitite
|
6.1%
3/49
|
Additional Information
Walter Ling, MD
UCLA Integrated Substance Abuse Programs
Phone: 310-267-5888
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place