Extended-release injectable suspension naltrexone (XR-NTX) as an adjunct pharmacotherapy for prevention of substance use in SUD patients who are currently in treatment for ADHD

Attention deficit hyperactivity disorder (ADHD) is a common co-morbidity in substance use disorders (SUD) that negatively impacts the course of the SUD.

Opioid antagonists such as naltrexone (NTX) are useful in the treatment of opiate and alcohol dependence, and, as shown recently by our group, also for amphetamine dependence.

Recommended pharmacotherapy for ADHD includes central stimulants but clinicians are reluctant to prescribe these due to lack of data on their efficacy and safety in ADHD/SUD.

This study investigates if extended release (XR)NTX (380 mg) reduces drug use in individuals with SUD also concurrently receiving central stimulant pharmacotherapy for ADHD. Participants meet DSM-5 criteria for SUD and ADHD. Alcohol, stimulant and opioid use disorder will all be included to increase the ecological validity.

Hypothesis: XR-NTX will increase the percentage of drug negative samples in urine (incl alcohol biomarker EtG), increase the retention in treatment and improve the clinical condition of patients.

Design: double-blind, randomized, placebo controlled, 12 weeks treatment + 12 weeks follow-up with continuous supervised urine testing, females/males; n=128 [see protocol for power calculation]. Twice weekly supervised urine test (24 weeks) and contingency management.

Primary outcome: ITT analysis of the proportion of urine samples free of drugs and alcohol biomarker [THC analyzed separately]; missing tests defined as positive. EudraCT 2016-004710-95; Ethics 2020-00558.