Clinical trial NCT02803229
Conditions: Cannabis Use Disorder Attention-deficit/Hyperactivity Disorder
Sponsor: New York State Psychiatric Institute
Start date: 2016-07-01; Completion date: 2020-06-01
Enrollment: 33 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The proposed protocol is a double-blind, placebo-controlled outpatient study of the safety and benefit of Extended-release mixed amphetamine salt (Adderall-XR, MAS-XR) in the treatment of individuals with Cannabis Use Disorder (CUD) and Attention-deficit/Hyperactivity Disorder (ADHD). The investigators plan to enroll 50 and randomize 40 of these patients in the trial. The primary objective of the study is to determine the efficacy of MAS-XR in promoting cannabis abstinence among individuals with CUD and in promoting a decrease of ADHD symptoms.

Detailed description:
ADHD is common in substance use disorder patients in general and cannabis use disorder (CUD) in particular, occurring at rates substantially greater than in the general population. A meta-analysis found that approximately 23% of substance abusers seeking treatment have childhood and/or adult ADHD. Moreover, ADHD was overrepresented in adults with CUD compared to other substance use disorder patients seeking treatment. The importance in treating CUD individuals who also have ADHD is underscored by findings demonstrating that individuals with co-occurring ADHD and substance use disorders are a particularly intractable group: they exhibit earlier onset of use, more severe use, a more complicated pattern of remission/relapse, and poorer treatment outcomes relative to those without ADHD. Yet, to date, ADHD individuals with CUD have not been adequately studied. The investigators have found that in their treatment research studies targeting cannabis dependence that a substantial percentage (35%) have screened positive for adult ADHD, rates that are higher than participants in their cocaine use disorder clinical trial and almost 8x greater than rates found in the general population. Thus, this appears to be a sizable cannabis-abusing group warranting much greater clinical attention than they are currently receiving.

The goal is to demonstrate feasibility, tolerability, and estimate effect size for purposes of planning future more definitive trials. Because of the research team's extensive experience in working with stimulant medication in treating ADHD in cocaine-dependent populations, the large effect size of amphetamine in treating adult ADHD, and notable reduction in cocaine use and ADHD symptoms in cocaine-dependent ADHD adults, the investigators will explore the efficacy of Adderall-XR (MAS-XR) for the treatment of cannabis use disorder and ADHD. The study is a 12 week placebo controlled double-blind trial. The maximum maintained dose will be 80 mg of MAS-XR daily.

Arms: arm 1: matched Placebo arm arm 2: Adderall-XR (MAS-XR) 80 mg/day maximum maintenance dose
Interventions: intervention 1: Adderall-XR intervention 2: Matched placebo
Intervention descriptions: intervention 1: None intervention 2: matched placebo provided for placebo arm

Protocol documents:
Prot_000.pdf: 
Study: # 7280 entitled Treatment of Cannabis Use Disorder among adults with co-morbid Attention-
Deficit/Hyperactivity Disorder 
 
PI: Frances R. Levin 
NCT# NCT02803229 
Study Protocol Date: June 07, 2016 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

































































SAP_001.pdf: 
Study: # 7280 entitled Treatment of Cannabis Use Disorder among adults with co-morbid Attention-
Deficit/Hyperactivity Disorder 
 
PI: Frances R. Levin 
NCT# NCT02803229 
Statistical Analysis Plan (Grant): October 29, 2015