Extended-Release Mixed Amphetamine Salts for Comorbid Adult Attention-Deficit/Hyperactivity Disorder and Cannabis Use Disorder: A Pilot, Randomized Double-Blind, Placebo-Controlled Trial.

Levin et al. ·Journal of attention disorders Impact 2.8

Mixed GRADE Moderate 3 citations

Samplen = 28 Pat.

Duration12 weeks

ControlPlacebo

EndpointAISRS

Blindingdoppelblind

DesignRCT

Key finding

No significant difference in ADHD symptom reduction or cannabis abstinence, but significant reduction in weekly cannabis use days under MAS-ER versus placebo.

Summary

12-week double-blind pilot RCT of MAS-ER 80 mg vs. placebo in comorbid ADHD and cannabis use disorder (CUD), n=28. No significant difference in ≥30% ADHD symptom reduction (MAS-ER 83,3% vs. placebo 71,4%; p=0.65) or cannabis abstinence in the last 2 weeks (MAS-ER 15,4% vs. placebo 0%; p=0.27). MAS-ER showed significant reduction in weekly cannabis use days over time vs. placebo (p<0.0001). Medication well tolerated.

PopulationAdults with comorbid ADHD and cannabis use disorder (CUD), n=28

InterventionExtended-Release Mixed Amphetamine Salts (MAS-ER) 80 mg/day orally

ControlPlacebo

OutcomeNo significant difference in ADHD symptom reduction (MAS-ER 83,3% vs. placebo 71,4%; p=0,65) or cannabis abstinence (15,4% vs. 0%; p=0,27); significant reduction in weekly cannabis use days under MAS-ER vs. placebo (p<0,0001)

Confidence in the evidence

Moderate

The third of four GRADE levels, the effect estimate is probably reliable.

Downgraded for

Imprecision

Quality profile

Sample size ★★★★★

Blinding Double-blind

Effect size Mixed

Citations / year ★★★★★

Authors

Levin FR, Mariani JJ, Pavlicova M, Choi CJ, Basaraba C, Mahony AL, Brooks DJ, Brezing CA, Naqvi N

DOI 10.1177/10870547241264675↗

Design: RCT

Abstract

Objective: To determine if treatment of co-occurring adult ADHD and Cannabis Use Disorder (CUD) with extended-release mixed amphetamine salts (MAS-ER) would be effective at improving ADHD symptoms and promoting abstinence. Method: A 12-week randomized, double-blind, two-arm pilot feasibility trial of adults with comorbid ADHD and CUD (n = 28) comparing MAS-ER (80 mg) to placebo. Main outcomes: Adhd: >/=30% symptom reduction, measured by the Adult ADHD Investigator Symptom Rating Scale (AISRS). Cud: Abstinence during last 2 observed weeks of maintenance phase. Results: Overall, medication was well-tolerated. There was no significant difference in ADHD symptom reduction (MAS-ER: 83.3%; placebo: 71.4%; p = .65) or cannabis abstinence (MAS-ER: 15.4%; placebo: 0%; p = .27). MAS-ER group showed a significant decrease in weekly cannabis use days over time compared to placebo (p < .0001). Conclusions: MAS-ER was generally well-tolerated. The small sample size precluded a determination of MAS-ER's superiority reducing ADHD symptoms or promoting abstinence. Notably, MAS-ER significantly reduced weekly days of use over time.

The impediment to action advances action. — Marcus Aurelius