Treatment of Cannabis Use Disorder Among Adults With Comorbid Attention-Deficit/Hyperactivity Disorder (MJ-ADHD)
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|ClinicalTrials.gov Identifier: NCT02803229|
Recruitment Status : Recruiting
First Posted : June 16, 2016
Last Update Posted : May 16, 2018
|Condition or disease||Intervention/treatment||Phase|
|Cannabis Use Disorder Attention-deficit/Hyperactivity Disorder||Drug: Adderall-XR Drug: Matched placebo||Phase 2 Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Treatment of Cannabis Use Disorder Among Adults With Comorbid Attention-Deficit/Hyperactivity Disorder|
|Study Start Date :||July 2016|
|Estimated Primary Completion Date :||June 2019|
|Estimated Study Completion Date :||September 2019|
Placebo Comparator: Placebo
matched Placebo arm
Drug: Matched placebo
matched placebo provided for placebo arm
Other Name: placebo
Adderall-XR (MAS-XR) 80 mg/day maximum maintenance dose
Other Name: Extended-release mixed amphetamine salt
- Marijuana abstinence [ Time Frame: Change from baseline compared to last 2 weeks of the 12 week study on maintained dose (weeks 10 and 11 for completers) or last 2 weeks of participants' participation during the study for participants who drop out of the study before weeks 10 and 11 ]defined as abstinence from marijuana during the last two weeks of the trial as recorded by theTimeline Followback method and confirmed by urine toxicology.
- Reduction in ADHD symptoms [ Time Frame: Change from baseline compared to last week of trial on maintained dose during the 12 week trial (week 11 for completers) or last week of participants' participation during the 12 week trial for those who drop out of study prior to week 11. ]The primary ADHD outcome measure will be the percentage of individuals who achieve at least a 30% reduction in symptom severity as measured by the Adult ADHD Interview Rating Scale (AISRS).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02803229
|Contact: Amy Mahony, LMHC||646-774-8183||Amy.firstname.lastname@example.org|
|Contact: Elizabeth Martinez||212-923-3031|
|United States, New York|
|New York Psychiatric Institute||Recruiting|
|New York, New York, United States, 10032|
|Contact: Elizabeth Martinez 212-923-3031|
|Principal Investigator: Frances R Levin, MD|
|Principal Investigator:||Frances R Levin, MD||New York Psychiatric Institute|