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
Qualifiers
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
Treatments tested in this trial
- extended-release naltrexone (XR-NTX)
- extended release bupropion (BUP-XL) tablets (BUP-XL)
- iPLB
- oPLB
Treatment groups
360 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov