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

Primary Purpose

Cannabis Use Disorder, Attention-deficit/Hyperactivity Disorder

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Adderall-XR
Matched placebo
Sponsored by
New York State Psychiatric Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cannabis Use Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 tetrahydrocannabinol (THC) on the day of study entry
  • Individuals must meet Diagnostic and Statistical Manual 5th ed. (DSM-5) criteria for adult ADHD
  • Individuals who score > 22 on the adult ADHD Investigator Symptom Rating Scale (AISRS)
  • 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 the end of the study, patients will be offered treatment 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 methylenedioxymethamphetamine (MDMA).
  • Individuals with a current cocaine use disorder

Sites / Locations

  • New York Psychiatric Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Adderall-XR

Arm Description

matched Placebo arm

Adderall-XR (MAS-XR) 80 mg/day maximum maintenance dose

Outcomes

Primary Outcome Measures

Marijuana Abstinence
Number of participants who achieve abstinence from marijuana during the last two weeks of the trial as recorded by the Timeline Followback method and confirmed by urine toxicology.
Reduction in ADHD Symptoms
The primary ADHD outcome measure will be the number of individuals who achieve at least a 30% reduction in symptom severity as measured by the Adult ADHD Interview Rating Scale (AISRS).

Secondary Outcome Measures

Full Information

First Posted
June 9, 2016
Last Updated
March 16, 2021
Sponsor
New York State Psychiatric Institute
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT02803229
Brief Title
Treatment of Cannabis Use Disorder Among Adults With Comorbid Attention-Deficit/Hyperactivity Disorder
Acronym
MJ-ADHD
Official Title
Treatment of Cannabis Use Disorder Among Adults With Comorbid Attention-Deficit/Hyperactivity Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
July 2016 (Actual)
Primary Completion Date
June 2020 (Actual)
Study Completion Date
June 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
New York State Psychiatric Institute
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cannabis Use Disorder, Attention-deficit/Hyperactivity Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
matched Placebo arm
Arm Title
Adderall-XR
Arm Type
Experimental
Arm Description
Adderall-XR (MAS-XR) 80 mg/day maximum maintenance dose
Intervention Type
Drug
Intervention Name(s)
Adderall-XR
Other Intervention Name(s)
Extended-release mixed amphetamine salt
Intervention Type
Drug
Intervention Name(s)
Matched placebo
Other Intervention Name(s)
placebo
Intervention Description
matched placebo provided for placebo arm
Primary Outcome Measure Information:
Title
Marijuana Abstinence
Description
Number of participants who achieve abstinence from marijuana during the last two weeks of the trial as recorded by the Timeline Followback method and confirmed by urine toxicology.
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
Title
Reduction in ADHD Symptoms
Description
The primary ADHD outcome measure will be the number of individuals who achieve at least a 30% reduction in symptom severity as measured by the Adult ADHD Interview Rating Scale (AISRS).
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 tetrahydrocannabinol (THC) on the day of study entry Individuals must meet Diagnostic and Statistical Manual 5th ed. (DSM-5) criteria for adult ADHD Individuals who score > 22 on the adult ADHD Investigator Symptom Rating Scale (AISRS) 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 the end of the study, patients will be offered treatment 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 methylenedioxymethamphetamine (MDMA). Individuals with a current cocaine use disorder
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frances R Levin, MD
Organizational Affiliation
New York Psychiatric Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York Psychiatric Institute
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Treatment of Cannabis Use Disorder Among Adults With Comorbid Attention-Deficit/Hyperactivity Disorder

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