Treatment of Cannabis Use Disorder Among Adults With Comorbid Attention-Deficit/Hyperactivity Disorder
Condition: Cannabis Use Disorder; Attention-deficit/Hyperactivity Disorder
MeSH terms: Hyperkinesis; Marijuana Abuse; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 2/Phase 3

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.
    

Intervention name(s): Adderall-XR; Matched placebo
Intervention type(s): Drug; Drug
Intervention description(s): matched placebo provided for placebo arm
Other intervention name(s): Extended-release mixed amphetamine salt; placebo
Intervention MeSH terms: Amphetamine; Adderall
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment