Trial Outcomes & Findings for Treatment of Cannabis Use Disorder Among Adults With Comorbid Attention-Deficit/Hyperactivity Disorder (NCT NCT02803229)

Last Updated: 2021-04-09

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

33 participants

Primary outcome timeframe

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

Results posted on

2021-04-09

Participant Flow

The study contained a one week placebo lead-in prior to randomization. Three participants were excluded due to being a placebo-responder and two participants were lost to follow-up during this lead-in week.

Participant milestones

Participant milestones
Measure	Placebo matched Placebo arm Matched placebo: matched placebo provided for placebo arm	Adderall-XR Adderall-XR (MAS-XR) 80 mg/day maximum maintenance dose Adderall-XR
Overall Study STARTED	15	13
Overall Study COMPLETED	11	7
Overall Study NOT COMPLETED	4	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=15 Participants matched Placebo arm Matched placebo: matched placebo provided for placebo arm	Adderall-XR n=13 Participants Adderall-XR (MAS-XR) 80 mg/day maximum maintenance dose Adderall-XR	Total n=28 Participants Total of all reporting groups
Age, Continuous	33.3 years STANDARD_DEVIATION 9.5 • n=5 Participants	32.4 years STANDARD_DEVIATION 11.2 • n=7 Participants	32.9 years STANDARD_DEVIATION 10.2 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	1 Participants n=7 Participants	6 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	12 Participants n=7 Participants	22 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=5 Participants	6 Participants n=7 Participants	11 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	10 Participants n=5 Participants	7 Participants n=7 Participants	17 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) White	8 Participants n=5 Participants	5 Participants n=7 Participants	13 Participants n=5 Participants
Race (NIH/OMB) More than one race	3 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	15 participants n=5 Participants	13 participants n=7 Participants	28 participants n=5 Participants
baseline cannabis use	26.9 days STANDARD_DEVIATION 1.7 • n=5 Participants	27.3 days STANDARD_DEVIATION 1.1 • n=7 Participants	27.1 days STANDARD_DEVIATION 1.4 • n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Placebo n=15 Participants matched Placebo arm Matched placebo: matched placebo provided for placebo arm	Adderall-XR n=13 Participants Adderall-XR (MAS-XR) 80 mg/day maximum maintenance dose Adderall-XR
Marijuana Abstinence	0 Participants	2 Participants

PRIMARY outcome

Timeframe: 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.

Population: One participant in each arm did not have any follow-up AISRS scores, so they were not included in the analysis.

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).

Outcome measures

Outcome measures
Measure	Placebo n=14 Participants matched Placebo arm Matched placebo: matched placebo provided for placebo arm	Adderall-XR n=12 Participants Adderall-XR (MAS-XR) 80 mg/day maximum maintenance dose Adderall-XR
Reduction in ADHD Symptoms	10 Participants	10 Participants

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Adderall-XR

Serious events: 1 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=15 participants at risk matched Placebo arm Matched placebo: matched placebo provided for placebo arm	Adderall-XR n=13 participants at risk Adderall-XR (MAS-XR) 80 mg/day maximum maintenance dose Adderall-XR
Cardiac disorders Atrial fibrillation (Afib)	0.00% 0/15 • 12 weeks of trial or length of participation.	7.7% 1/13 • Number of events 1 • 12 weeks of trial or length of participation.

Other adverse events

Additional Information

Frances R Levin, MD

New York State Psychiatric Institute

Phone: 6467746137

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Placebo n=15 participants at risk matched Placebo arm Matched placebo: matched placebo provided for placebo arm	Adderall-XR n=13 participants at risk Adderall-XR (MAS-XR) 80 mg/day maximum maintenance dose Adderall-XR
General disorders insomnia	6.7% 1/15 • Number of events 1 • 12 weeks of trial or length of participation.	23.1% 3/13 • Number of events 3 • 12 weeks of trial or length of participation.
Psychiatric disorders anxiety	6.7% 1/15 • Number of events 1 • 12 weeks of trial or length of participation.	15.4% 2/13 • Number of events 2 • 12 weeks of trial or length of participation.
General disorders chest pain	0.00% 0/15 • 12 weeks of trial or length of participation.	15.4% 2/13 • Number of events 2 • 12 weeks of trial or length of participation.
General disorders headache	6.7% 1/15 • Number of events 1 • 12 weeks of trial or length of participation.	7.7% 1/13 • Number of events 1 • 12 weeks of trial or length of participation.
General disorders nervousness	6.7% 1/15 • Number of events 1 • 12 weeks of trial or length of participation.	7.7% 1/13 • Number of events 1 • 12 weeks of trial or length of participation.
Gastrointestinal disorders anorexia	0.00% 0/15 • 12 weeks of trial or length of participation.	7.7% 1/13 • Number of events 1 • 12 weeks of trial or length of participation.
Musculoskeletal and connective tissue disorders arm numbness	0.00% 0/15 • 12 weeks of trial or length of participation.	7.7% 1/13 • Number of events 1 • 12 weeks of trial or length of participation.
Musculoskeletal and connective tissue disorders backache	0.00% 0/15 • 12 weeks of trial or length of participation.	7.7% 1/13 • Number of events 1 • 12 weeks of trial or length of participation.
Musculoskeletal and connective tissue disorders cramps	6.7% 1/15 • Number of events 1 • 12 weeks of trial or length of participation.	0.00% 0/13 • 12 weeks of trial or length of participation.
General disorders dizziness	0.00% 0/15 • 12 weeks of trial or length of participation.	7.7% 1/13 • Number of events 1 • 12 weeks of trial or length of participation.
General disorders erectile dysfunction	0.00% 0/15 • 12 weeks of trial or length of participation.	7.7% 1/13 • Number of events 1 • 12 weeks of trial or length of participation.
Cardiac disorders hypertension	0.00% 0/15 • 12 weeks of trial or length of participation.	7.7% 1/13 • Number of events 1 • 12 weeks of trial or length of participation.
General disorders irritability	0.00% 0/15 • 12 weeks of trial or length of participation.	7.7% 1/13 • Number of events 1 • 12 weeks of trial or length of participation.
General disorders jittery	0.00% 0/15 • 12 weeks of trial or length of participation.	7.7% 1/13 • Number of events 1 • 12 weeks of trial or length of participation.
Nervous system disorders psychomotor agitation	6.7% 1/15 • Number of events 1 • 12 weeks of trial or length of participation.	0.00% 0/13 • 12 weeks of trial or length of participation.
Respiratory, thoracic and mediastinal disorders shortness of breath	0.00% 0/15 • 12 weeks of trial or length of participation.	7.7% 1/13 • Number of events 1 • 12 weeks of trial or length of participation.
Nervous system disorders tremor	0.00% 0/15 • 12 weeks of trial or length of participation.	7.7% 1/13 • Number of events 1 • 12 weeks of trial or length of participation.
Respiratory, thoracic and mediastinal disorders upper respiratory infection	6.7% 1/15 • Number of events 1 • 12 weeks of trial or length of participation.	0.00% 0/13 • 12 weeks of trial or length of participation.
General disorders weight loss	0.00% 0/15 • 12 weeks of trial or length of participation.	7.7% 1/13 • Number of events 1 • 12 weeks of trial or length of participation.