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Cannabinoids in Attention- Deficit/Hyperactivity Disorder: A Randomised-Controlled Trial Ruth Cooper Post-Doctoral Researcher

Cannabinoids in Attention-Deficit/Hyperactivity Disorder ... · –Self-medication –Alternative treatment –Novel treatment mechanism –Controversial 1 • Limitations –Failure

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Page 1: Cannabinoids in Attention-Deficit/Hyperactivity Disorder ... · –Self-medication –Alternative treatment –Novel treatment mechanism –Controversial 1 • Limitations –Failure

Cannabinoids in Attention-Deficit/Hyperactivity Disorder: A Randomised-Controlled Trial

Ruth Cooper

Post-Doctoral Researcher

Page 2: Cannabinoids in Attention-Deficit/Hyperactivity Disorder ... · –Self-medication –Alternative treatment –Novel treatment mechanism –Controversial 1 • Limitations –Failure

Disclosures

• This study was funded through a departmental research account for Prof Asherson. The placebo and active medication were provided free of charge by GW Pharma Ltd. GW Pharma played no role in study design, data collection, data analysis, data interpretation, or writing of the report.

• At the time this work was undertaken, Ruth Cooper was a PhD student at King’s College London, funded by a research grant to Prof Asherson from Vifor Pharma.

Page 3: Cannabinoids in Attention-Deficit/Hyperactivity Disorder ... · –Self-medication –Alternative treatment –Novel treatment mechanism –Controversial 1 • Limitations –Failure

ADHDInattention

Hyperactivity/Impulsivity

Cognitive deficits2

Emotional lability1

1. Skirrow & Asherson (2012), 2. Wilcutt et al (2005)

Page 4: Cannabinoids in Attention-Deficit/Hyperactivity Disorder ... · –Self-medication –Alternative treatment –Novel treatment mechanism –Controversial 1 • Limitations –Failure

ADHD and Cannabis

• Substance abuse:

– stimulants and cannabis1,2

• Self medication?

1. Lee et al (2011), 2. Asherson et al (unpublished data)

Page 5: Cannabinoids in Attention-Deficit/Hyperactivity Disorder ... · –Self-medication –Alternative treatment –Novel treatment mechanism –Controversial 1 • Limitations –Failure

“It makes me more productive”

“I’m able to think clearer”

“Slows my constant thoughts”

Page 6: Cannabinoids in Attention-Deficit/Hyperactivity Disorder ... · –Self-medication –Alternative treatment –Novel treatment mechanism –Controversial 1 • Limitations –Failure

ADHD and Cannabis

Page 7: Cannabinoids in Attention-Deficit/Hyperactivity Disorder ... · –Self-medication –Alternative treatment –Novel treatment mechanism –Controversial 1 • Limitations –Failure

The EMA-C Study• Design:

⁻ Randomised controlled trial

⁻ 6 weeks

• Participants:

⁻ 30 unmedicated adults with ADHD

• Intervention:

⁻ Sativex (THC:CBD)

⁻ Placebo

Cooper et al., under review

• Primary endpoint:⁻ Cognitive performance

/activity

• Secondary endpoints⁻ ADHD symptoms⁻ Emotional lability

Page 8: Cannabinoids in Attention-Deficit/Hyperactivity Disorder ... · –Self-medication –Alternative treatment –Novel treatment mechanism –Controversial 1 • Limitations –Failure

The EMA-C Study

1. Will treatment with Sativex improve cognitive performance?

2. Will treatment with Sativex improve symptoms of ADHD and emotional lability?

Page 9: Cannabinoids in Attention-Deficit/Hyperactivity Disorder ... · –Self-medication –Alternative treatment –Novel treatment mechanism –Controversial 1 • Limitations –Failure

The EMA-C Study

30 adults with ADHD

15Active

15Placebo

15Active

11Placebo

4 Weeks

2 WeeksTitration

Page 10: Cannabinoids in Attention-Deficit/Hyperactivity Disorder ... · –Self-medication –Alternative treatment –Novel treatment mechanism –Controversial 1 • Limitations –Failure

Results: Cognitive performance

Time x group: p = 0.16, Est = -0.2

1

1,1

1,2

1,3

1,4

1,5

1,6

1,7

1,8

Baseline Follow-up

Qb

Te

st

Placebo

Active

Page 11: Cannabinoids in Attention-Deficit/Hyperactivity Disorder ... · –Self-medication –Alternative treatment –Novel treatment mechanism –Controversial 1 • Limitations –Failure

Results: Hyp/Imp

Time x group: p = 0.03, Est = -2.5

0

2

4

6

8

10

12

14

16

18

20

Baseline Follow-up

Hyp

/Im

p

Placebo

Active

Page 12: Cannabinoids in Attention-Deficit/Hyperactivity Disorder ... · –Self-medication –Alternative treatment –Novel treatment mechanism –Controversial 1 • Limitations –Failure

Results: Inattention

Time x group: p = 0.10, Est = -2.4

0

5

10

15

20

25

30

Baseline Follow-up

Inat

ten

tio

n

Placebo

Active

Page 13: Cannabinoids in Attention-Deficit/Hyperactivity Disorder ... · –Self-medication –Alternative treatment –Novel treatment mechanism –Controversial 1 • Limitations –Failure

Results: Emotional lability

Time x group: p = 0.11, Est = -3.8

0

5

10

15

20

25

30

35

Baseline Follow-up

Emo

tio

nal

Lab

ility

Placebo

Active

Page 14: Cannabinoids in Attention-Deficit/Hyperactivity Disorder ... · –Self-medication –Alternative treatment –Novel treatment mechanism –Controversial 1 • Limitations –Failure

Conclusion• First cannabinoid trial

• Feasible

• Promising results

– No negative effects

– Nominally sig/Non-sig improvements

– Similar to improvements after stimulant medication

Page 15: Cannabinoids in Attention-Deficit/Hyperactivity Disorder ... · –Self-medication –Alternative treatment –Novel treatment mechanism –Controversial 1 • Limitations –Failure

Conclusion• Clinical implications

– Self-medication

– Alternative treatment

– Novel treatment mechanism

– Controversial1

• Limitations

– Failure of the blind

– Power

• Future directions

– Larger trial

1. Volkow et al., 2014

Page 16: Cannabinoids in Attention-Deficit/Hyperactivity Disorder ... · –Self-medication –Alternative treatment –Novel treatment mechanism –Controversial 1 • Limitations –Failure

Acknowledgements

• Participants

• Supervisors:

– Philip Asherson

– Charlotte Tye

• Co-Authors:

– Emma Williams

– Seth Seegobin

– Jonna Kuntsi

• GW Pharma