Fixed or Self-Titrated Dosages of Sativex on Cannabis Users

• Sponsor: Centre for Addiction and Mental Health (Other)
• Overall Status: Completed
• CT.gov ID: NCT01748799
• Collaborator: Canadian Institutes of Health Research (CIHR) (Other)
• Enrollment: 16
• Location: 1
• Arms: 8
• Duration (Months): 19
• Patients Per Site Per Month: 0.8

Study Details

Study Description

Brief Summary

The purpose of this study is to to demonstrate the feasibility and tolerability of the use of Sativex in cannabis dependent individuals and to assess the effects of fixed or self titrated dosages of SATIVEX® (Δ9-tetrahydrocannabinol /cannabidiol combination in a buccal spray) on withdrawal symptoms, craving scores and cannabis consumption during the study period.

Condition or Disease	Intervention/Treatment	Phase
Cannabis Dependence	Drug: Sativex; Drug: Placebo	N/A

Detailed Description

This will be a one year pilot/feasibility study, assessing the effects of fixed or self-titrated dosages of SATIVEX® (Δ9-tetrahydrocannabinol /cannabidiol combination in a buccal spray) on withdrawal from cannabis and craving among cannabis dependent subjects. Subjects in this study will undergo an 8-week double-blind, placebo-controlled trial. Subjects will be regular cannabis-users who are not currently seeking treatment for cannabis dependence. Subjects will participate in each of 8 conditions, lasting 5 weekdays each (an ABACADAE study design); four smoke as usual conditions (SAU) and four cannabis abstinence conditions. During each abstinence condition (B, C, D, E conditions), subjects will be allocated to one condition including self-titration of placebo, fixed dose of placebo, self-titration of SATIVEX (up to a max of 40 sprays per day, equal to 108mg THC) or fixed dose of SATIVEX (40 sprays per day). Each medication phase will be followed by a washout period where individuals will be requested to smoke cannabis as usual (A condition). The experimental conditions will be: type of SATIVEX® spray used (active vs placebo), and titration regimen (fixed or self-titrated). This pilot study will allow us to demonstrate the feasibility of our approach and to determine the sample size to use secondarily for a larger study. Our ultimate goal is to determine optimal conditions to use for a subsequent randomized controlled trial assessing the efficacy of SATIVEX® in treatment of Cannabis dependence among treatment-seeking subjects.

Study Design

• Study Type: Interventional
• Actual Enrollment: 16 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: Effects of Fixed or Self-Titrated Dosages of Sativex on Cannabis Users
• Study Start Date: Feb 1, 2013
• Actual Primary Completion Date: Sep 1, 2014
• Actual Study Completion Date: Sep 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Other: Sequence 1 Self-titrated placebo - Self-titrated Sativex - Fixed dose Sativex - Fixed dose placebo	Drug: Sativex; All participants received the same interventions (Fixed or Self-Titrated Sativex), just in different sequences.; Other Names: Delta-9-tetrahydrocannabinol and cannabidiol ; Drug: Placebo; All participants received the same interventions (Fixed or Self-Titrated Placebo), just in different sequences.; Other Names: Ethanol, propylene glycol and peppermint oil with colors
Other: Sequence 2 Fixed dose placebo - Fixed dose Sativex - Self-titrated Sativex - Self-titrated placebo	Drug: Sativex; All participants received the same interventions (Fixed or Self-Titrated Sativex), just in different sequences.; Other Names: Delta-9-tetrahydrocannabinol and cannabidiol ; Drug: Placebo; All participants received the same interventions (Fixed or Self-Titrated Placebo), just in different sequences.; Other Names: Ethanol, propylene glycol and peppermint oil with colors
Other: Sequence 3 Fixed dose placebo - Fixed dose Sativex - Self-titrated placebo - Self-titrated Sativex	Drug: Sativex; All participants received the same interventions (Fixed or Self-Titrated Sativex), just in different sequences.; Other Names: Delta-9-tetrahydrocannabinol and cannabidiol ; Drug: Placebo; All participants received the same interventions (Fixed or Self-Titrated Placebo), just in different sequences.; Other Names: Ethanol, propylene glycol and peppermint oil with colors
Other: Sequence 4 Fixed dose Sativex - Fixed dose placebo - Self-titrated placebo - Self-titrated Sativex	Drug: Sativex; All participants received the same interventions (Fixed or Self-Titrated Sativex), just in different sequences.; Other Names: Delta-9-tetrahydrocannabinol and cannabidiol ; Drug: Placebo; All participants received the same interventions (Fixed or Self-Titrated Placebo), just in different sequences.; Other Names: Ethanol, propylene glycol and peppermint oil with colors
Other: Sequence 5 Self-titrated Sativex - Self-titrated placebo - Fixed dose Sativex - Fixed dose placebo	Drug: Sativex; All participants received the same interventions (Fixed or Self-Titrated Sativex), just in different sequences.; Other Names: Delta-9-tetrahydrocannabinol and cannabidiol ; Drug: Placebo; All participants received the same interventions (Fixed or Self-Titrated Placebo), just in different sequences.; Other Names: Ethanol, propylene glycol and peppermint oil with colors
Other: Sequence 6 Self-titrated Sativex - Self-titrated placebo - Fixed dose placebo - Fixed dose Sativex	Drug: Sativex; All participants received the same interventions (Fixed or Self-Titrated Sativex), just in different sequences.; Other Names: Delta-9-tetrahydrocannabinol and cannabidiol ; Drug: Placebo; All participants received the same interventions (Fixed or Self-Titrated Placebo), just in different sequences.; Other Names: Ethanol, propylene glycol and peppermint oil with colors
Other: Sequence 7 Self-titrated placebo - Self-titrated Sativex - Fixed dose placebo - Fixed dose Sativex	Drug: Sativex; All participants received the same interventions (Fixed or Self-Titrated Sativex), just in different sequences.; Other Names: Delta-9-tetrahydrocannabinol and cannabidiol ; Drug: Placebo; All participants received the same interventions (Fixed or Self-Titrated Placebo), just in different sequences.; Other Names: Ethanol, propylene glycol and peppermint oil with colors
Other: Sequence 8 Fixed dose Sativex - Fixed dose placebo - Self-titrated Sativex - Self-titrated placebo	Drug: Sativex; All participants received the same interventions (Fixed or Self-Titrated Sativex), just in different sequences.; Other Names: Delta-9-tetrahydrocannabinol and cannabidiol ; Drug: Placebo; All participants received the same interventions (Fixed or Self-Titrated Placebo), just in different sequences.; Other Names: Ethanol, propylene glycol and peppermint oil with colors

Outcome Measures

Primary Outcome Measures

1. Feasibility [12 months]

   Feasibility will be assessed by analysing how many participants can be recruited/complete the whole (randomly assigned) experimental sequence with a period of one year.

Secondary Outcome Measures

1. Tolerability of Sativex in Persons That Are Cannabis Dependent [8 weeks]

   To assess what number of participants might withdrew due non-tolerability of Sativex

2. Cannabis Withdrawal [8 weeks]

   Withdrawal symptoms were assessed using the Cannabis Withdrawal Scale (CWS) (Minimum-Maximum Scores 0-190, high scores represent more withdrawal) and Cannabis Withdrawal Checklist (CWC) (Minimum-Maximum Scores 0-48, high scores represent more withdrawal) by establishing comparisons between Sativex/Placebo and Smoke as usual conditions (4 interventions: Fixed Sativex, Fixed Placebo, Self-titrated Sativex, Self-titrated Placebo and 4 corresponding Smoke as usual conditions).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• age 18-50

• current cannabis dependence

• cannabis as primary drug of abuse

• frequent cannabis use (i.e., at least 5 days per week)

• have experienced at least 2 withdrawal symptoms during previous cessation periods

• cannabis use not for medical purposes (i.e., not a government-licensed medical cannabis user)

• not seeking treatment for cannabis dependence

• willingness to participate in study protocol

Exclusion Criteria:

• meet criteria for any psychiatric disorder requiring psychiatric intervention

• have a history of seizures; c)have known sensitivity to Dronabinol, Cannabidiol, Propylene glycole, Ethanol or peppermint oil (used in Sativex buccal spray

• suffer from an unstable medical condition

• currently have physical dependence on any other drugs (excluding nicotine) that would require medical detoxification

• currently taking psychotropic medication with benefit for any other illness than treatment of insomnia

• pregnant or breast-feeding

• hold a job that involves operating heavy machinery

• currently seeking treatment for cannabis-related problems

• family history of psychotic symptoms

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centre for Addiction and Mental Health	Toronto	Ontario	Canada	M5S 2S1

Sponsors and Collaborators

• Centre for Addiction and Mental Health
• Canadian Institutes of Health Research (CIHR)

Investigators

• Principal Investigator: Bernard Le Foll, Centre for Addiction and Mental Health

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Information about research at the Centre for Addiction and Mental Health, Canada's largest mental health and addiction teaching hospital, fully affiliated with the University of Toronto, and a PAHO/WHO Collaborating Centre

Publications

None provided.

• Responsible Party: Bernard Le Foll, Head, Translational Addiction Research Laboratory, Centre for Addiction and Mental Health
• ClinicalTrials.gov Identifier: NCT01748799
• Other Study ID Numbers: 103/2011; 243152
• First Posted: Dec 13, 2012
• Last Update Posted: Feb 1, 2016
• Last Verified: Oct 1, 2015

• Keywords provided by Bernard Le Foll, Head, Translational Addiction Research Laboratory, Centre for Addiction and Mental Health: Cannabis dependence; Sativex
• Additional relevant MeSH terms: Marijuana Abuse; Ethanol; Nabiximols; Dronabinol; Cannabidiol; Peppermint oil

Study Results

Participant Flow

Arm/Group Title	Sequence 1	Sequence 2	Sequence 3	Sequence 4	Sequence 5	Sequence 6	Sequence 7	Sequence 8
Arm/Group Description	Self-titrated placebo - Self-titrated Sativex - Fixed dose Sativex - Fixed dose placebo	Fixed dose placebo - Fixed dose Sativex - Self-titrated Sativex - Self-titrated placebo	Fixed dose placebo - Fixed dose Sativex - Self-titrated placebo - Self-titrated Sativex	Fixed dose Sativex - Fixed dose placebo - Self-titrated placebo - Self-titrated Sativex	Self-titrated Sativex - Self-titrated placebo - Fixed dose Sativex - Fixed dose placebo	Self-titrated Sativex - Self-titrated placebo - Fixed dose placebo - Fixed dose Sativex	Self-titrated placebo - Self-titrated Sativex - Fixed dose placebo - Fixed dose Sativex	Fixed dose Sativex - Fixed dose placebo - Self-titrated Sativex - Self-titrated placebo
Period Title: Overall Study
STARTED	6	1	1	2	1	2	2	1
Completed SAU of Fixed Dose Placebo	2	1	1	2	1	1	1	1
Completed Fixed Dose Placebo	2	1	1	2	1	1	1	1
Completed SAU of Fixed Dose Sativex	1	1	1	2	1	1	1	1
Completed Fixed Dose Sativex	1	1	1	2	1	1	1	1
Completed SAU of Self-titrated Placebo	5	1	1	2	1	2	1	1
Completed Self-titrated Placebo	4	1	1	2	1	2	1	1
Completed SAU of Self-titrated Sativex	2	1	1	2	1	2	1	1
Completed Self-titrated Sativex	1	1	1	2	1	1	1	1
COMPLETED	1	1	1	2	1	1	1	1
NOT COMPLETED	5	0	0	0	0	1	1	0

Baseline Characteristics

Arm/Group Title	Sequence 1	Sequence 2	Sequence 3	Sequence 4	Sequence 5	Sequence 6	Sequence 7	Sequence 8	Total
Arm/Group Description	Self-titrated placebo - Self-titrated Sativex - Fixed dose Sativex - Fixed dose placebo	Fixed dose placebo - Fixed dose Sativex - Self-titrated Sativex - Self-titrated placebo	Fixed dose placebo - Fixed dose Sativex - Self-titrated placebo - Self-titrated Sativex	Fixed dose Sativex - Fixed dose placebo - Self-titrated placebo - Self-titrated Sativex	Self-titrated Sativex - Self-titrated placebo - Fixed dose Sativex - Fixed dose placebo	Self-titrated Sativex - Self-titrated placebo - Fixed dose placebo - Fixed dose Sativex	Self-titrated placebo - Self-titrated Sativex - Fixed dose placebo - Fixed dose Sativex	Fixed dose Sativex - Fixed dose placebo - Self-titrated Sativex - Self-titrated placebo	Total of all reporting groups
Overall Participants	6	1	1	2	1	2	2	1	16
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	35.7 (8.6)	24.0 (0.0)	19.0 (0.0)	46.5 (6.4)	36.0 (0.0)	41.5 (6.4)	43.0 (5.6)	22.0 (0.0)	34.8 (10.5)
Sex: Female, Male (Count of Participants)
Female	2 33.3%	1 100%	0 0%	0 0%	0 0%	0 0%	1 50%	0 0%	4 25%
Male	4 66.7%	0 0%	1 100%	2 100%	1 100%	2 100%	1 50%	1 100%	12 75%
Region of Enrollment (participants) [Number]
Canada	6 100%	1 100%	1 100%	2 100%	1 100%	2 100%	2 100%	1 100%	16 100%

Outcome Measures

1. Primary Outcome

Title	Feasibility
Description	Feasibility will be assessed by analysing how many participants can be recruited/complete the whole (randomly assigned) experimental sequence with a period of one year.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

16 participants were enrolled in the study, 9 participants completed the whole (randomly assigned) experimental sequence

Arm/Group Title	Sequence 1	Sequence 2	Sequence 3	Sequence 4	Sequence 5	Sequence 6	Sequence 7	Sequence 8
Arm/Group Description	Self-titrated placebo - Self-titrated Sativex - Fixed dose Sativex - Fixed dose placebo	Fixed dose placebo - Fixed dose Sativex - Self-titrated Sativex - Self-titrated placebo	Fixed dose placebo - Fixed dose Sativex - Self-titrated placebo - Self-titrated Sativex	Fixed dose Sativex - Fixed dose placebo - Self-titrated placebo - Self-titrated Sativex	Self-titrated Sativex - Self-titrated placebo - Fixed dose Sativex - Fixed dose placebo	Self-titrated Sativex - Self-titrated placebo - Fixed dose placebo - Fixed dose Sativex	Self-titrated placebo - Self-titrated Sativex - Fixed dose placebo - Fixed dose Sativex	Fixed dose Sativex - Fixed dose placebo - Self-titrated Sativex - Self-titrated placebo
Measure Participants	6	1	1	2	1	2	2	1
Number [participants]	1 16.7%	1 100%	1 100%	2 100%	1 100%	1 50%	1 50%	1 100%

2. Secondary Outcome

Title	Tolerability of Sativex in Persons That Are Cannabis Dependent
Description	To assess what number of participants might withdrew due non-tolerability of Sativex
Time Frame	8 weeks

Outcome Measure Data

Analysis Population Description

Data from 16 participants enrolled in the study was analyzed, none of the participants withdrew due non-tolerability of Sativex

Arm/Group Title	Sequence 1	Sequence 2	Sequence 3	Sequence 4	Sequence 5	Sequence 6	Sequence 7	Sequence 8
Arm/Group Description	Self-titrated placebo - Self-titrated Sativex - Fixed dose Sativex - Fixed dose placebo	Fixed dose placebo - Fixed dose Sativex - Self-titrated Sativex - Self-titrated placebo	Fixed dose placebo - Fixed dose Sativex - Self-titrated placebo - Self-titrated Sativex	Fixed dose Sativex - Fixed dose placebo - Self-titrated placebo - Self-titrated Sativex	Self-titrated Sativex - Self-titrated placebo - Fixed dose Sativex - Fixed dose placebo	Self-titrated Sativex - Self-titrated placebo - Fixed dose placebo - Fixed dose Sativex	Self-titrated placebo - Self-titrated Sativex - Fixed dose placebo - Fixed dose Sativex	Fixed dose Sativex - Fixed dose placebo - Self-titrated Sativex - Self-titrated placebo
Measure Participants	6	1	1	2	1	2	2	1
Number [participants]	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%

3. Secondary Outcome

Title	Cannabis Withdrawal
Description	Withdrawal symptoms were assessed using the Cannabis Withdrawal Scale (CWS) (Minimum-Maximum Scores 0-190, high scores represent more withdrawal) and Cannabis Withdrawal Checklist (CWC) (Minimum-Maximum Scores 0-48, high scores represent more withdrawal) by establishing comparisons between Sativex/Placebo and Smoke as usual conditions (4 interventions: Fixed Sativex, Fixed Placebo, Self-titrated Sativex, Self-titrated Placebo and 4 corresponding Smoke as usual conditions).
Time Frame	8 weeks

Outcome Measure Data

Analysis Population Description

Only 9 of the 16 participants recruited completed the whole experimental sequence (participants were assigned to 1 of 8 different experimental sequences in a randomized order).

Arm/Group Title	Fixed Dose Sativex	Smoke as Usual FS	Self-titrated Sativex	Smoke as Usual StS	Fixed Dose Placebo	Smoke as Usual FP	Self-titrated Placebo	Smoke as Usual StP
Arm/Group Description	Participants were requested to abstain from using cannabis and take a fixed dose of Sativex during this condition (40 sprays per day). Each abstinence condition was followed by a smoke as usual condition (SAU).	Smoke as usual condition corresponding to Fixed Sativex	Participants were requested to abstain from using cannabis and self-titrate dosages of Sativex (up to 40 sprays per day) during this condition. Each abstinence condition was followed by a smoke as usual condition (SAU).	Smoke as usual condition corresponding to Self-titrated Sativex	Participants were requested to abstain from using cannabis and administer a fixed dose of placebo daily (40 sprays per day). Each abstinence condition was followed by a smoke as usual condition (SAU).	Smoke as usual condition corresponding to Fixed Placebo	Participants were requested to abstain from using cannabis and self-titrate dosages of placebo (up to 40 sprays per day) during this condition. Each abstinence condition was followed by a smoke as usual condition (SAU).	Smoke as usual condition corresponding to Self-titrated Placebo
Measure Participants	9	9	9	9	9	9	9	9
Cannabis Withdrawal Scale (CWS)	10.3 (12.2)	7.9 (10.0)	9.8 (10.9)	6.6 (5.8)	17.9 (15.9)	8.6 (11.4)	13.7 (14.5)	7.5 (8.3)
Cannabis Withdrawal Checklist (CWC) Total	3.6 (3.5)	2.6 (2.0)	4.0 (4.2)	2.3 (2.2)	7.4 (5.9)	3.7 (3.4)	5.9 (5.5)	3.0 (1.6)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Sequence 1, Sequence 2, Sequence 3, Sequence 4, Sequence 5, Sequence 6, Sequence 7, Sequence 8
	Comments	Omnibus analysis for Cannabis Withdrawal Scale (CWS) data was a Repeated measures ANOVA (including all the experimental conditions) followed by pair-wise comparisons. The level for statistical significance was p< 0.05.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.01
	Comments	The level for statistical significance was p< 0.05.
	Method	ANOVA
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Sequence 1, Sequence 2, Sequence 3, Sequence 4, Sequence 5, Sequence 6, Sequence 7, Sequence 8
	Comments	Omnibus analysis for Cannabis Withdrawal Checklist (CWC) data was a Repeated measures ANOVA (including all the experimental conditions) followed by pair-wise comparisons. The level for statistical significance was p< 0.05.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.01
	Comments	The level for statistical significance was p< 0.05.
	Method	ANOVA
	Comments

Adverse Events

Time Frame	8 weeks
Adverse Event Reporting Description	Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.
Arm/Group Title	Fixed Dose Sativex		Smoke as Usual FS		Self-titrated Sativex		Smoke as Usual StS		Fixed Dose Placebo		Smoke as Usual FP		Self-titrated Placebo		Smoke as Usual StP
Arm/Group Description	Participants were requested to abstain from using cannabis and take a fixed dose of Sativex during this condition (40 sprays per day). Each abstinence condition was followed by a smoke as usual condition (SAU).		Smoke as usual condition corresponding to Fixed Sativex		Participants were requested to abstain from using cannabis and self-titrate dosages of Sativex (up to 40 sprays per day) during this condition. Each abstinence condition was followed by a smoke as usual condition (SAU).		Smoke as usual condition corresponding to Self-titrated Sativex		Participants were requested to abstain from using cannabis and take a fixed dose of placebo during this condition (40 sprays per day). Each abstinence condition was followed by a smoke as usual condition (SAU).		Smoke as usual condition corresponding to Fixed placebo		Participants were requested to abstain from using cannabis and self-titrate dosages of placebo (up to 40 sprays per day) during this condition. Each abstinence condition was followed by a smoke as usual condition (SAU).		Smoke as usual condition corresponding to Self-titrated placebo
All Cause Mortality
	Fixed Dose Sativex		Smoke as Usual FS		Self-titrated Sativex		Smoke as Usual StS		Fixed Dose Placebo		Smoke as Usual FP		Self-titrated Placebo		Smoke as Usual StP
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Fixed Dose Sativex		Smoke as Usual FS		Self-titrated Sativex		Smoke as Usual StS		Fixed Dose Placebo		Smoke as Usual FP		Self-titrated Placebo		Smoke as Usual StP
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/9 (0%)		0/9 (0%)		0/9 (0%)		0/11 (0%)		0/10 (0%)		0/10 (0%)		0/13 (0%)		0/14 (0%)
Other (Not Including Serious) Adverse Events
	Fixed Dose Sativex		Smoke as Usual FS		Self-titrated Sativex		Smoke as Usual StS		Fixed Dose Placebo		Smoke as Usual FP		Self-titrated Placebo		Smoke as Usual StP
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	5/9 (55.6%)		1/9 (11.1%)		7/9 (77.8%)		3/11 (27.3%)		5/10 (50%)		5/10 (50%)		9/13 (69.2%)		9/14 (64.3%)
Blood and lymphatic system disorders
hot flashes	1/9 (11.1%)	1	0/9 (0%)	1	0/9 (0%)	0	0/11 (0%)	0	1/10 (10%)	1	0/10 (0%)	1	1/13 (7.7%)	2	0/14 (0%)	2
Ear and labyrinth disorders
Ringing ears	0/9 (0%)		1/9 (11.1%)	1	0/9 (0%)	1	1/11 (9.1%)	2	0/10 (0%)	2	0/10 (0%)	2	0/13 (0%)	2	0/14 (0%)	2
Eye disorders
Dry eyes	0/9 (0%)		0/9 (0%)		0/9 (0%)		0/11 (0%)		0/10 (0%)		0/10 (0%)		1/13 (7.7%)	1	0/14 (0%)	1
Gastrointestinal disorders
Nausea	0/9 (0%)	0	0/9 (0%)	0	3/9 (33.3%)	3	0/11 (0%)	3	1/10 (10%)	1	0/10 (0%)	1	0/13 (0%)	0	0/14 (0%)	0
Diarrhea	0/9 (0%)	0	0/9 (0%)	0	2/9 (22.2%)	2	0/11 (0%)	2	0/10 (0%)	0	0/10 (0%)	0	0/13 (0%)	0	4/14 (28.6%)	4
heartburn	0/9 (0%)	0	0/9 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	2/13 (15.4%)	2	0/14 (0%)	2
Stomach Pain	0/9 (0%)		0/9 (0%)		0/9 (0%)		1/11 (9.1%)	1	0/10 (0%)	1	0/10 (0%)	1	0/13 (0%)	1	0/14 (0%)	1
General disorders
Headache	1/9 (11.1%)	1	0/9 (0%)	1	0/9 (0%)	0	0/11 (0%)	0	1/10 (10%)	1	1/10 (10%)	1	3/13 (23.1%)	3	1/14 (7.1%)	1
Impaired taste sensation of food	0/9 (0%)	0	0/9 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	1/10 (10%)	1	0/10 (0%)	1	1/13 (7.7%)	1	0/14 (0%)	1
Vertigo	1/9 (11.1%)	1	0/9 (0%)	1	1/9 (11.1%)	1	1/11 (9.1%)	1	1/10 (10%)	1	0/10 (0%)	1	0/13 (0%)	0	0/14 (0%)	0
Feeling drowsy	0/9 (0%)		0/9 (0%)		0/9 (0%)		0/11 (0%)		0/10 (0%)		0/10 (0%)		1/13 (7.7%)	1	1/14 (7.1%)	1
Musculoskeletal and connective tissue disorders
Pain in the knee	0/9 (0%)	0	0/9 (0%)	0	1/9 (11.1%)	1	0/11 (0%)	1	0/10 (0%)	0	0/10 (0%)	0	1/13 (7.7%)	1	0/14 (0%)	1
Scapula pain	0/9 (0%)	0	0/9 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	1/10 (10%)	1	0/10 (0%)	1	0/13 (0%)	0	0/14 (0%)	0
Sore foot	0/9 (0%)	0	0/9 (0%)	0	1/9 (11.1%)	1	1/11 (9.1%)	1	0/10 (0%)	0	0/10 (0%)	0	0/13 (0%)	0	0/14 (0%)	0
Back pain	0/9 (0%)		0/9 (0%)		0/9 (0%)		0/11 (0%)		0/10 (0%)		2/10 (20%)	2	0/13 (0%)	2	0/14 (0%)	2
Ankle pain	0/9 (0%)		0/9 (0%)		0/9 (0%)		0/11 (0%)		0/10 (0%)		0/10 (0%)		0/13 (0%)		1/14 (7.1%)	1
Psychiatric disorders
Insomnia	1/9 (11.1%)	1	0/9 (0%)	1	1/9 (11.1%)	1	0/11 (0%)	1	3/10 (30%)	3	0/10 (0%)	3	1/13 (7.7%)	1	1/14 (7.1%)	1
Nightmares	0/9 (0%)	0	0/9 (0%)	0	0/9 (0%)	0	1/11 (9.1%)	1	1/10 (10%)	1	0/10 (0%)	1	0/13 (0%)	0	0/14 (0%)	0
Low motivation	0/9 (0%)		0/9 (0%)		0/9 (0%)		1/11 (9.1%)	1	0/10 (0%)	1	0/10 (0%)	1	0/13 (0%)	1	0/14 (0%)	1
Anxiety	0/9 (0%)		0/9 (0%)		0/9 (0%)		1/11 (9.1%)	1	0/10 (0%)	1	0/10 (0%)	1	0/13 (0%)	1	1/14 (7.1%)	1
Respiratory, thoracic and mediastinal disorders
Cold	0/9 (0%)	0	0/9 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	1/10 (10%)	1	3/10 (30%)	3	3/13 (23.1%)	3	0/14 (0%)	3
Sore Throat	1/9 (11.1%)	1	0/9 (0%)	1	0/9 (0%)	0	0/11 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	1/13 (7.7%)	1	0/14 (0%)	1
Runny nose	0/9 (0%)		0/9 (0%)		1/9 (11.1%)	1	0/11 (0%)	1	0/10 (0%)	1	0/10 (0%)	1	0/13 (0%)	0	1/14 (7.1%)	1
Skin and subcutaneous tissue disorders
Rash	0/9 (0%)		0/9 (0%)		0/9 (0%)		0/11 (0%)		0/10 (0%)		0/10 (0%)		2/13 (15.4%)	2	1/14 (7.1%)	1

Limitations/Caveats

The main limitation is the small sample size. Also our study did not include experimental conditions containing THC alone and CBD alone for comparison. The short duration of the experimental condition is also a limitation.

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Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.