Cannabis Use DisorderPhase 2/3MJ-ADHDNCT02803229
Treatment of Cannabis Use Disorder Among Adults With Comorbid Attention-Deficit/Hyperactivity Disorder
A Phase 2/3 study testing Adderall-XR in people with Cannabis Use Disorder and Attention-deficit/Hyperactivity Disorder, run by New York State Psychiatric Institute at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cannabis Use Disorder, Attention-deficit/Hyperactivity Disorder
- What is being tested?
- Adderall-XR
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2016to Jun 2020
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
New York Psychiatric Institute
New York, New York, 10032
About this study
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.
Read the 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.
- Being tested
- Adderall-XR, Matched placebo
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adderall-XRDrug
Also called Extended-release mixed amphetamine salt
Matched placeboDrug
Also called placebo
matched placebo provided for placebo arm
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | matched Placebo arm Receives: Drug: Matched placebo |
| Adderall-XR | Experimental | Adderall-XR (MAS-XR) 80 mg/day maximum maintenance dose Receives: Drug: Adderall-XR |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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).
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2016 (estimated)
- Study startJul 2016
- Primary completionJun 2020
- Study completionJun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cannabis Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Frances R Levin, New York State Psychiatric Institute
- Investigators
- Frances R Levin, MD, Principal investigator, New York Psychiatric Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02803229
- Sponsor's protocol ID
- 7280
- Other IDs
- U54DA037842-01
- Acronym
- MJ-ADHD
- Status last verified
- Mar 2021
- First submitted
- 9 Jun 2016
- Last updated
- 9 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Cannabis Use Disorder Among Adults With Comorbid Attention-Deficit/Hyperactivity Disorder
- ClinicalTrials.gov ID
- NCT02803229
- Acronym / sponsor ID
- MJ-ADHD / 7280
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Jul 2016 (actual)
- Primary completion
- Jun 2020 (actual)
- Study completion
- Jun 2020 (actual)
- First posted
- 16 Jun 2016 (estimated)
- Results
- Posted 9 Apr 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Matched placebomatched Placebo arm |
| Adderall-XR | Experimental | Drug: Adderall-XRAdderall-XR (MAS-XR) 80 mg/day maximum maintenance dose |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adderall-XRAlso: Extended-release mixed amphetamine salt | Drug | Adderall-XR |
| Matched placeboAlso: placebomatched placebo provided for placebo arm | Drug | Placebo |
Primary outcome
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
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
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 number of individuals who achieve at least a 30% reduction in symptom severity as measured by the Adult ADHD Interview Rating Scale (AISRS).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frances R Levin, MD principal investigator
New York Psychiatric Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Adderall-XR in people with Cannabis Use Disorder and Attention-deficit/Hyperactivity Disorder, run by New York State Psychiatric Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2021.