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Trial record 41 of 138 for:    cannabis | Recruiting, Enrolling by invitation Studies

Treatment of Cannabis Use Disorder Among Adults With Comorbid Attention-Deficit/Hyperactivity Disorder (MJ-ADHD)

This study is currently recruiting participants.
Verified March 2017 by New York State Psychiatric Institute
Sponsor:
ClinicalTrials.gov Identifier:
NCT02803229
First Posted: June 16, 2016
Last Update Posted: April 5, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
New York State Psychiatric Institute
June 9, 2016
June 16, 2016
April 5, 2017
July 2016
June 2018   (Final data collection date for primary outcome measure)
  • 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).
  • Marijuana abstinence [ Time Frame: last two weeks of the 12 week study on maintained dose (weeks 10 and 11 for completers) or last two weeks of participants' particpation duirng the 12 week study ]
    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: 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 ]
    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).
Complete list of historical versions of study NCT02803229 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Treatment of Cannabis Use Disorder Among Adults With Comorbid Attention-Deficit/Hyperactivity Disorder
Treatment of Cannabis Use Disorder Among Adults With Comorbid Attention-Deficit/Hyperactivity Disorder
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.

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.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Cannabis Use Disorder
  • Attention-deficit/Hyperactivity Disorder
  • Drug: Adderall-XR
    Other Name: Extended-release mixed amphetamine salt
  • Drug: Matched placebo
    matched placebo provided for placebo arm
    Other Name: placebo
  • Placebo Comparator: Placebo
    matched Placebo arm
    Intervention: Drug: Matched placebo
  • Experimental: Adderall-XR
    Adderall-XR (MAS-XR) 80 mg/day maximum maintenance dose
    Intervention: Drug: Adderall-XR
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
September 2018
June 2018   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Individuals who meet criteria for cannabis use disorder (CUD) and report that marijuana is their primary drug of abuse
  • Individuals must report using marijuana at least 5 days a week over the past 28 days and have a positive urine test for THC on the day of study entry
  • Individuals must meet DSM-5 criteria for adult ADHD
  • Individuals who score > 22 on the AISRS scale
  • Individuals between the ages of 18-65 capable of giving informed consent and capable of complying with study procedures
  • Women of child-bearing age will be included if they: a) are not pregnant, b) agree to use an effective method of contraception, c) agree not to become pregnant during the study and d) are not breastfeeding. To confirm this, urine pregnancy tests will be repeated every month after screening. Women will be provided a full explanation of the potential dangers of pregnancy while taking MAS-XR. If a woman becomes pregnant, she will be taken off medication and continue standard treatment at STARS. At the end of the study, patients will be offered treatment at STARS until an appropriate referral can be made to a community clinic.

Exclusion Criteria:

  • Individuals meeting DSM-5 criteria for schizophrenia, schizoaffective illness, psychotic disorder other than transient psychosis due to drug abuse, current major depression, bipolar illness or psychiatric disorders (other than substance abuse) which require psychiatric intervention or would interfere with study participation
  • Individuals who are medically unstable based on laboratory tests, electrocardiogram, medical history, physical examination that would make participation hazardous
  • Use of synthetic cannabinoids in the past month and meeting CUD diagnosis based on synthetic cannabinoids use alone in the past year
  • Individuals with liver enzyme function tests greater than 3 times normal
  • Individuals with significant current suicidal risk
  • Individuals with systolic blood pressure > 140; diastolic blood pressure >90; pulse >100
  • Individuals who are cognitively impaired to impede study participation
  • Nursing mothers and pregnant women
  • Individuals who are physiologically dependent on any other drugs (excluding nicotine) that would require a medical intervention
  • Individuals with known sensitivity/allergy to MAS-XR or amphetamine analogs
  • Individuals currently being prescribed psychotropic medication (including sleep medication)
  • Individuals with history of seizures
  • Individuals who are mandated to treatment
  • Individuals with a history of amphetamine use disorders, including amphetamines such as methamphetamine and MDMA.
  • Individuals with a current cocaine use disorder
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact: Amy Mahony, LMHC 646-774-8183 mahonya@nyspi.columbia.edu
Contact: Elizabeth Martinez 212-923-3031
United States
 
 
NCT02803229
7280
U54DA037842-01 ( U.S. NIH Grant/Contract )
Yes
Not Provided
Plan to Share IPD: No
New York State Psychiatric Institute
New York State Psychiatric Institute
National Institute on Drug Abuse (NIDA)
Principal Investigator: Frances R Levin, MD New York Psychiatric Institute
New York State Psychiatric Institute
March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP