Trial of Naltrexone/Bupropion for the Treatment of Methamphetamine Use Disorder
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-65
SponsorNational Institute on Drug Abuse (NIDA)
About this trial
The primary objective of this study is to evaluate the efficacy of extended release naltrexone plus bupropion XL (XR-NTX/BUP-XL) compared to matched injectable and oral placebo (iPLB/oPLB) in reducing methamphetamine (MA) use in individuals with moderate or severe methamphetamine use disorder (MUD) seeking to stop or reduce MA use.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Is 18 to 65 years of age;
Meets DSM-5 criteria for moderate or severe MUD (4 or more criteria);
Is interested in reducing or stopping MA use;
Is able to speak English sufficiently to understand the study procedures and provide written informed consent to participate in the study;
Disqualifiers
Has an acute medical or psychiatric disorder that would, in the judgment of the study medical clinician, make participation difficult or unsafe;
Has suicidal or homicidal ideation that requires immediate attention;
Has a history of epilepsy, seizure disorder, or head trauma with neurological sequelae (e.g., loss of consciousness that required hospitalization); current anorexia nervosa or bulimia; or any other conditions that increase seizure risk in the opinion of the study medical clinician;
Has evidence of second or third degree heart block, atrial fibrillation, atrial flutter, prolongation of the QTc, or any other finding on the screening ECG that, in the opinion of the study medical clinician, would preclude safe participation in the study;
Trial design
Design model
Parallel
Treatments tested in this trial
extended-release naltrexone (XR-NTX)
DrugOnce per three weeks injections of extended-release naltrexone
extended release bupropion (BUP-XL) tablets (BUP-XL)
DrugDaily oral extended release bupropion tablets
iPLB
DrugOnce per three weeks injections of placebo
oPLB
DrugDaily oral placebo tablets
Treatment groups
360 Participants
are divided into 2 treatment groupsGroup A: XR-NTX/BUP-XLExperimental treatment 2 interventions
Group B: PLB/PLBPlacebo comparator 2 interventions
Trial outcomes
Primary outcomes
1
Number of Participants with at least 75% methamphetamine-negative urine drug screen tests during the evaluation period (i. e., Weeks 11-12)
Participants will be administered four urine drug screen tests (two tests/week) during the evaluation period. (i.e., Weeks 11-12).
Time frame
2 weeks (i. e., Weeks 11-12)Secondary outcomes
1
safety measured as frequency and severity of adverse events (AEs)
adverse events (AEs), clinical lab tests, suicidality
Time frame
16 weeks (12 week treatment plus followup)2
Severity of Craving as measured by Visual Analog Scale
Craving score as assessed by Visual Analog Scale that ranges from 0 (no craving) to 100 (most intense craving possible). The Visual Analog Scale will be completed at each screening visit, twice weekly throughout the treatment phase, and at the Week 14 and 16 follow-up visits.
Time frame
16 weeks (12 week treatment plus followup)3
Severity of Depression as assessed by the Patient Health Questionnaire-9
Diagnostic criteria for major depression, severity and frequency of depressive symptoms, presence of suicidal ideation, and functional impairment related to depression will be assessed by the Patient Health Questionnaire-9 (Kroenke et al., 2001)
Time frame
16 weeks (12 week treatment plus followup)4
Treatment Effectiveness as measured by the Treatment Effectiveness Assessment
The Treatment Effectiveness Assessment (TEA; Ling et al., 2012) is a 4-item self-administered assessment to document changes in four life domains: substance use, personal responsibilities, health, and community. The TEA will be collected at screening, mid-treatment (Week 6 visit 2), end-of-treatment (Week 12 visit 2), and follow-up (Weeks 14 and 16).
Time frame
16 weeks (12 week treatment plus followup)Sponsors and contacts
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Source ClinicalTrials.gov