Acute and Short-term Effects of Cannabidiol Admin on Cue-induced Craving in Drug-abstinent Heroin Dependent Humans

• ClinicalTrials.gov Identifier: NCT01605539
• Recruitment Status: Completed
• First Posted: May 25, 2012
• Results First Posted: November 28, 2016
• Last Update Posted: November 28, 2016
• Sponsor: Hurd,Yasmin, Ph.D.
• Information provided by (Responsible Party): Yasmin Hurd, Hurd,Yasmin, Ph.D.

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Opiate Addiction
• Interventions: Drug: Cannabidiol 400; Drug: Cannabidiol 800; Drug: Control
• Enrollment: 10

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Control	CBD 400 Group	CBD 800 Group
Arm/Group Description	Subjects will receive pills that resemble the Cannabidiol capsule but do not have have its properties. Control: Subjects will receive a harmless, inactive pill to compare and validate the results of the other arms of the study	Subjects will receive 400 mg of cannabidiol Subjects in Arm CBD 400 will receive 400 mg of Cannabidiol in each of the three test sessions	Subjects in Arm CBD 800 will receive 800 mg of Cannabidiol in each of the three test sessions
Period Title: Overall Study
Started	3	3	4
Completed	3	2	4
Not Completed	0	1	0

Baseline Characteristics

Arm/Group Title		Control	CBD Group	Total
Arm/Group Description		Subjects received pills that resemble the Cannabidiol capsule but did not have its properties. Control: Subjects receivd a harmless, inactive pill to compare and validate the results of the other arms of the study	The two arms (400 mg and 800 mg of Cannabidiol) were combined for analysis because the sample size was too small and dividing the two arms would not have yielded a meaningful analysis. Cannabidiol: Subjects in Arm CBD Group received 400 mg or 800mg of Cannabidiol in each of the three test sessions	Total of all reporting groups
Overall Number of Baseline Participants		3	6	9
Baseline Analysis Population Description		[Not Specified]
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	3 participants	6 participants	9 participants
	<=18 years	0 0.0%	0 0.0%	0 0.0%
	Between 18 and 65 years	3 100.0%	6 100.0%	9 100.0%
	>=65 years	0 0.0%	0 0.0%	0 0.0%
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	3 participants	6 participants	9 participants
	Female	0 0.0%	0 0.0%	0 0.0%
	Male	3 100.0%	6 100.0%	9 100.0%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
United States	Number Analyzed	3 participants	6 participants	9 participants
		3	6	9

Outcome Measures

1. Primary Outcome

Title	Changes in Cue-Induced In-Clinic Craving (From Baseline to Post-cue or Post-neutral - Via the Visual Analog Scale for Craving (VASC)
Description	The VASC will be administered to assess potential variations in the subjective craving effects associated with heroin. Following the administration of the investigational drug, craving induced in response to the cue sessions and neutral cue sessions in the clinic will be measured. In this way, changes in craving from baseline (pre-cue to post-cue and pre-neutral cue to post-neutral cue) within each test visit) will be measured and compared. Scale range: 0 (no craving) - 10 (extreme craving). **For test visits I, II and IV, there will be two cue sessions at each test visit: a neutral cue video (PN) and a drug-related cue video (PC) will be shown in random order at each visit. Before the beginning of each cue session (PN or PC), baseline measures will be taken. The same questionnaires will be administered immediately following the neutral cue video and the drug-related cue video. Thus there will be two sets of baselines and two sets of post cue measurements per test visit for test
Time Frame	VASC: test visits I, II and IV - baseline 1, post cue (PC), baseline 2, post neutral cue (PN)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control	CBD Group
Arm/Group Description:	Subjects received pills that resemble the Cannabidiol capsule but do not have have its properties. Control: Subjects received a harmless, inactive pill to compare and validate the results of the other arms of the study	Subjects received 400 mg or 800mg of cannabidiol.The two arms (400 mg and 800 mg CBD groups) were combined for analysis as CPD Group because the sample size was too small and dividing the two arms would not have yielded a meaningful analysis. Cannabidiol: Subjects in Arm CBD Group received 400 mg or 800mg of Cannabidiol in each of the three test sessions
Overall Number of Participants Analyzed	3	6
Mean (Standard Error); Unit of Measure: units on a scale
Test 1: Baseline to Post Drug Cue	2.67 (1.45)	0.83 (0.31)
Test 1: Baseline to Post Neutral Cue	-0.33 (0.33)	-0.17 (0.17)
Test 2: Baseline to Post Drug Cue	0.670 (0.33)	0.67 (0.71)
Test 2: Baseline to Post Neutral Cue	-0.33 (0.67)	-0.67 (0.71)
Test 4: Baseline to Post Drug Cue	0.33 (0.33)	0.33 (0.21)
Test 4: Baseline to Post Neutral Cue	1.00 (0.58)	-0.50 (0.22)

2. Primary Outcome

Title	Changes in Out-of-Clinic Craving (From Pre-Dose to Approximately 6 Hours Post-Dose for Test Visits I and II; and From Pre-Dose Test Visit I to Pre-Cue Test Visit IV) - Via the Heroin Craving Questionnaire (HCQ)
Description	Subjects will be asked to complete the short version of the HCQ on their own time at home and bring it with them when they return for their next visit. Upon arrival to the clinic, subjects will also complete an HCQ with the coordinator to assess daily baseline cravings. This questionnaire will help us assess changes in craving generated outside of the clinical laboratory session from test visit 1 through test visit 4. Scale: 1 (strongly disagree) - 7 (strongly agree). Total Score Range: 14 (less cravings) - 98 (more cravings). ** The baseline measure for this outcome will be measured at the beginning of test session I prior to the administration of CBD/Placebo. Test measures will be taken approximately 6 hours following each dose for test sessions I, II and III. The final measure will be taken at test session IV, at the beginning of the session.
Time Frame	Test I and II: Change from pre-dose to approx. 6 hours post-dose; Change from pre-dose test visit I to pre-cue test visit IV

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control	CBD Group
Arm/Group Description:	Subjects received pills that resembled the Cannabidiol capsule but did not have have its properties. Control: Subjects received a harmless, inactive pill to compare and validate the results of the other arms of the study	Subjects received 400 mg or 800mg of cannabidiol. The two arms (400 mg and 800 mg CBD groups) were combined for analysis as CPD Group because the sample size was too small and dividing the two arms would not have yielded a meaningful analysis. Subjects in Arm CBD will receive 400 mg or 800mg of Cannabidiol in each of the three test sessions
Overall Number of Participants Analyzed	3	6
Mean (Standard Error); Unit of Measure: units on a scale
Test 1: Change from pre-dose to 6 hrs post-dose	-3.67 (2.73)	-0.33 (3.57)
Test 2: Change from pre-dose to 6 hrs post-dose	-5.33 (15.43)	-6.17 (1.11)
Change from Test 1 (pre-dose) to Test 4 (pre-cue)	-4.33 (7.69)	-16.33 (3.97)

3. Secondary Outcome

Title	Vital Signs - Blood Pressure
Description	Blood pressure (mmHg) will be monitored throughout the time course of the study and changes from baseline will be studied across the various time points. **For test visits I, II and IV, there will be two cue sessions at each test visit: a neutral cue video (PN) and a drug-related cue video (PC) will be shown in random order at each visit. Before the beginning of each cue session (PN or PC), baseline measures will be taken. Blood pressure will be measured again following the neutral cue video and the drug-related cue video. Thus there will be two sets of baselines and two sets of post cue measurements per test visit for test visits I, II and IV.
Time Frame	Test sessions 1,2,and 4: baseline 1, post cue (PC), baseline 2, post neutral cue (PN)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control	CBD Group
Arm/Group Description:	Subjects received pills that resemble the Cannabidiol capsule but do not have have its properties. Control: Subjects received a harmless, inactive pill to compare and validate the results of the other arms of the study	Subjects received 400 mg or 800mg of cannabidiol. The two arms (400 mg and 800 mg CBD groups) were combined for analysis as CPD Group because the sample size was too small and dividing the two arms would not have yielded a meaningful analysis. Subjects in Arm CBD received 400 mg or 800mg of Cannabidiol in each of the three test sessions
Overall Number of Participants Analyzed	3	6
Mean (Standard Error); Unit of Measure: mmHg
Systolic BP change (mmHG): test 1, baseline to PC	8.33 (3.76)	4.5 (3.66)
Systolic BP change (mmHG): test 1, baseline to PN	-0.33 (1.20)	0.17 (3.60)
Systolic BP change (mmHG): Test 2, baseline to PC	-8.67 (5.17)	8.5 (5.37)
Systolic BP change (mmHG): test 2, baseline to PN	5.00 (3.79)	4.83 (3.78)
Systolic BP change (mmHG): Test 4, baseline to PC	1.00 (2.52)	-6.33 (4.65)
Systolic BP change (mmHG): test 4, baseline to PN	-11.67 (4.06)	9.67 (6.23)
Diastolic BP change (mmHG): test 1, baseline to PC	6.33 (1.33)	5.33 (2.63)
Diastolic BP change (mmHG): test 1 baseline to PN	-0.33 (2.19)	1.5 (2.51)
Diastolic BP change (mmHG): test 2 baseline to PC	-4 (2.65)	1.83 (3.33)
Diastolic BP change (mmHG): test 2 baseline to PN	3.67 (3.93)	0.83 (2.20)
Diastolic BP change (mmHG): test 4 baseline to PC	-0.33 (1.45)	0.67 (3.34)
Diastolic BP change (mmHG): test 4 baseline to PN	-3.67 (4.91)	-1.33 (4.62)

4. Secondary Outcome

Title	Visual Analog Scale for Anxiety (VASA)
Description	Questionnaires will be used to measure subjective responses. Anxiety will be assessed using a visual analog scale for anxiety (VASA). Scale: 0 (not at all anxious) - 10 (extremely anxious). **For test visits I, II and IV, there will be two cue sessions at each test visit: a neutral cue video (PN) and a drug-related cue video (PC) will be shown in random order at each visit. Before the beginning of each cue session (PN or PC), baseline measures will be taken for each variable. The same variables will be measured following the neutral cue video and the drug-related cue video. Thus there will be two sets of baselines and two sets of post cue measurements per test visit for test visits I, II and IV.
Time Frame	Test visit I, II and IV: baseline 1, post cue (PC), baseline 2, post neutral cue (PN)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control	CBD Group
Arm/Group Description:	Subjects received pills that resemble the Cannabidiol capsule but do not have have its properties. Control: Subjects received a harmless, inactive pill to compare and validate the results of the other arms of the study	Subjects received 400 mg or 800mg of cannabidiol. The two arms (400 mg and 800 mg CBD groups) were combined for analysis as CPD Group because the sample size was too small and dividing the two arms would not have yielded a meaningful analysis. Subjects in Arm CBD received 400 mg or 800mg of Cannabidiol in each of the three test sessions
Overall Number of Participants Analyzed	3	6
Mean (Standard Error); Unit of Measure: units on a scale
Test 1: Baseline to Post Drug Cue	2.00 (1.15)	0.00 (0.26)
Test 1: Baseline to Post Neutral Cue	0.33 (0.33)	-0.33 (0.21)
Test 2: Baseline to Post Drug Cue	1.33 (1.20)	-0.50 (0.34)
Test 2: Baseline to Post Neutral Cue	-0.67 (0.88)	-0.50 (0.34)
Test 4: Baseline to Post Drug Cue	0.00 (0.00)	0.00 (0.00)
Test 4: Baseline to Post Neutral Cue	-0.67 (0.67)	-0.33 (0.21)

5. Secondary Outcome

Title	The Positive and Negative Affect Schedule (PANAS) - Positive Affect Schedule (PAS) Data
Description	Questionnaires will be used to measure subjective responses. The Positive and Negative Affect Schedule will allow us to obtain positive and negative affect measures and observe their changes from baseline over the course of the cue-induced craving session. Scale: 0 (only slightly or not at all) - 5 (extremely). Total Score Range for Positive Affect Assessment (PAS): 10 (minimum) - 50 (maximum). Higher score reflects stronger positive affect. **For test visits I, II and IV, there will be two cue sessions at each test visit: a neutral cue video (PN) and a drug-related cue video (PC) will be shown in random order at each visit. Before the beginning of each cue session (PN or PC), baseline measures will be taken for each variable. The same variables will be measured following the neutral cue video and the drug-related cue video. Thus there will be two sets of baselines and two sets of post cue measurements per test visit for test visits I, II and IV.
Time Frame	Test session 1, 2, and 4: baseline 1, post cue (PC), baseline 2, post neutral cue (PN)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control	CBD Group
Arm/Group Description:	Subjects received pills that resemble the Cannabidiol capsule but do not have have its properties. Control: Subjects received a harmless, inactive pill to compare and validate the results of the other arms of the study	Subjects received 400 mg or 800mg of cannabidiol. The two arms (400 mg and 800 mg CBD groups) were combined for analysis as CPD Group because the sample size was too small and dividing the two arms would not have yielded a meaningful analysis. Subjects in Arm CBD received 400 mg or 800mg of Cannabidiol in each of the three test sessions
Overall Number of Participants Analyzed	3	6
Mean (Standard Error); Unit of Measure: units on a scale
Test 1: Baseline to Post Drug Cue	1.33 (2.40)	-0.50 (1.88)
Test 1: Baseline to Post-Neutral Cue	1.33 (1.20)	-1.83 (0.83)
Test 2: Baseline to Post Drug Cue	-4.00 (1.73)	-1.00 (1.03)
Test 2: Baseline to Post Neutral Cue	-4.67 (2.40)	0.17 (1.01)
Test 4: Baseline to Post Drug Cue	-3.50 (3.50)	-1.33 (0.61)
Test 4: Baseline to Post Neutral Cue	2.50 (2.50)	0.67 (0.49)

6. Secondary Outcome

Title	The Positive and Negative Affect Schedule (PANAS) - Negative Affect Schedule (NAS) Data
Description	Questionnaires will be used to measure subjective responses. The Positive and Negative Affect Schedule will allow us to obtain positive and negative affect measures and observe their changes from baseline over the course of the cue-induced craving session. Scale: 0 (only slightly or not at all) - 5 (extremely). Total Score Range for Negative Affect Assessment (NAS): 10 (minimum) - 50 (maximum). Higher score reflects stronger negative affect. **For test visits I, II and IV, there will be two cue sessions at each test visit: a neutral cue video (PN) and a drug-related cue video (PC) will be shown in random order at each visit. Before the beginning of each cue session (PN or PC), baseline measures will be taken for each variable. The same variables will be measured following the neutral cue video and the drug-related cue video. Thus there will be two sets of baselines and two sets of post cue measurements per test visit for test visits I, II and IV.
Time Frame	Test session 1, 2, and 4: baseline 1, post cue (PC), baseline 2, post neutral cue (PN)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control	CBD Group
Arm/Group Description:	Subjects received pills that resemble the Cannabidiol capsule but do not have have its properties. Control: Subjects received a harmless, inactive pill to compare and validate the results of the other arms of the study	Subjects received 400 mg or 800mg of cannabidiol. The two arms (400 mg and 800 mg CBD groups) were combined for analysis as CPD Group because the sample size was too small and dividing the two arms would not have yielded a meaningful analysis. Subjects in Arm CBD received 400 mg or 800mg of Cannabidiol in each of the three test sessions
Overall Number of Participants Analyzed	3	6
Mean (Standard Error); Unit of Measure: units on a scale
Test 1: Baseline to Post Drug Cue	4.00 (3.51)	0.50 (0.92)
Test 1: Baseline to Post Neutral Cue	1.33 (0.88)	-1.50 (0.67)
Test 2: Baseline to Post Drug Cue	4.00 (7.55)	0.00 (1.29)
Test 2: Baseline to Post Neutral Cue	-0.33 (3.28)	0.17 (0.17)
Test 4: Baseline to Post Drug Cue	-1.50 (0.50)	0.33 (0.21)
Test 4: Baseline to Post Neutral Cue	-7.00 (8.00)	-0.67 (0.67)

7. Secondary Outcome

Title	Vital Signs - Heart Rate
Description	Heart rate (in beats/min) will be monitored throughout the time course of the study and changes from baseline will be studied across the various time points. **For test visits I, II and IV, there will be two cue sessions at each test visit: a neutral cue video (PN) and a drug-related cue video (PC) will be shown in random order at each visit. Before the beginning of each cue session (PN or PC), baseline measures will be taken. Heart rate will be measured again following the neutral cue video and the drug-related cue video. Thus there will be two sets of baselines and two sets of post cue measurements per test visit for test visits I, II and IV.
Time Frame	Test sessions 1,2,and 4: baseline 1, post cue (PC), baseline 2, post neutral cue (PN)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control	CBD Group
Arm/Group Description:	Subjects received pills that resemble the Cannabidiol capsule but do not have have its properties. Control: Subjects received a harmless, inactive pill to compare and validate the results of the other arms of the study	Subjects received 400 mg or 800mg of cannabidiol. The two arms (400 mg and 800 mg CBD groups) were combined for analysis as CPD Group because the sample size was too small and dividing the two arms would not have yielded a meaningful analysis. Subjects in Arm CBD received 400 mg or 800mg of Cannabidiol in each of the three test sessions
Overall Number of Participants Analyzed	3	6
Mean (Standard Error); Unit of Measure: beats per minute
Heart rate change (bpm): test 1 baseline to PC	-2.33 (1.67)	4.00 (2.21)
Heart rate change (bpm): test 1 baseline to PN	-6 (7.55)	2.5 (2.72)
Heart rate change (bpm): test 2 baseline to PC	-8 (3.06)	-6.5 (3.15)
Heart rate change (bpm): test 2 baseline to PN	-1.33 (0.67)	-3.33 (2.5)
Heart rate change (bpm): test 4 baseline to PC	0 (1.15)	-3.33 (1.78)
Heart rate change (bpm): test 4 baseline to PN	-1.67 (2.67)	-2.17 (2.5)

8. Secondary Outcome

Title	Vital Signs - Respiratory Rate
Description	Respiratory rate (in breaths/min) will be monitored throughout the time course of the study and changes from baseline will be studied across the various time points. **For test visits I, II and IV, there will be two cue sessions at each test visit: a neutral cue video (PN) and a drug-related cue video (PC) will be shown in random order at each visit. Before the beginning of each cue session (PN or PC), baseline measures will be taken. Respiratory rate will be measured again following the neutral cue video and the drug-related cue video. Thus there will be two sets of baselines and two sets of post cue measurements per test visit for test visits I, II and IV.
Time Frame	Test sessions 1,2,and 4: baseline 1, post cue (PC), baseline 2, post neutral cue (PN)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control	CBD Group
Arm/Group Description:	Subjects received pills that resemble the Cannabidiol capsule but do not have have its properties. Control: Subjects received a harmless, inactive pill to compare and validate the results of the other arms of the study	Subjects received 400 mg or 800mg of cannabidiol. The two arms (400 mg and 800 mg CBD groups) were combined for analysis as CPD Group because the sample size was too small and dividing the two arms would not have yielded a meaningful analysis. Subjects in Arm CBD received 400 mg or 800mg of Cannabidiol in each of the three test sessions
Overall Number of Participants Analyzed	3	6
Mean (Standard Error); Unit of Measure: breaths per minute
Respiratory rate (bpm): test 1 baseline to PC	0 (0)	0 (0.52)
Respiratory rate (bpm): test 1 baseline to PN	0 (0)	0 (0.52)
Respiratory rate (bpm): test 2 baseline to PC	-0.67 (0.67)	0 (0.52)
Respiratory rate (bpm): test 2 baseline to PN	0 (0)	-1 (0.45)
Respiratory rate (bpm): test 4 baseline to PC	-0.67 (0.67)	-0.67 (0.42)
Respiratory rate (bpm): test 4 baseline to PN	-0.67 (0.67)	0.33 (0.33)

9. Secondary Outcome

Title	Vital Signs - Temperature
Description	Temperature (in degrees Fahrenheit) will be monitored throughout the time course of the study and changes from baseline will be studied across the various time points. **For test visits I, II and IV, there will be two cue sessions at each test visit: a neutral cue video (PN) and a drug-related cue video (PC) will be shown in random order at each visit. Before the beginning of each cue session (PN or PC), baseline measures will be taken. Temperature will be measured again following the neutral cue video and the drug-related cue video. Thus there will be two sets of baselines and two sets of post cue measurements per test visit for test visits I, II and IV.
Time Frame	Test sessions 1,2,and 4: baseline 1, post cue (PC), baseline 2, post neutral cue (PN)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control	CBD Group
Arm/Group Description:	Subjects received pills that resemble the Cannabidiol capsule but do not have have its properties. Control: Subjects received a harmless, inactive pill to compare and validate the results of the other arms of the study	Subjects received 400 mg or 800mg of cannabidiol. The two arms (400 mg and 800 mg CBD groups) were combined for analysis as CPD Group because the sample size was too small and dividing the two arms would not have yielded a meaningful analysis. Subjects in Arm CBD received 400 mg or 800mg of Cannabidiol in each of the three test sessions
Overall Number of Participants Analyzed	3	6
Mean (Standard Error); Unit of Measure: degrees F
Temperature change (F): test 1 baseline to PC	0.03 (0.03)	-3.35 (3.33)
Temperature change (F): test 1 baseline to PN	0.43 (0.75)	0.03 (0.13)
Temperature change (F): test 2 baseline to PC	0.0 (0.1)	0.05 (0.10)
Temperature change (F): test 2 baseline to PN	0 (0.2)	0.02 (0.19)
Temperature change (F): test 4 baseline to PC	0.3 (0.31)	0.18 (0.08)
Temperature change (F): test 4 baseline to PN	0.13 (0.28)	-0.17 (0.09)

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	Adverse events were collected by using SAFTEE (Systematic Assessment for Treatment Emergent Events)
Arm/Group Title	Control		CBD Group
Arm/Group Description	Subjects received pills that resemble the Cannabidiol capsule but do not have have its properties. Control: Subjects received a harmless, inactive pill to compare and validate the results of the other arms of the study		Subjects received 400 mg or 800mg of cannabidiol.The two arms (400 mg and 800 mg CBD groups) were combined for analysis as CPD Group because the sample size was too small and dividing the two arms would not have yielded a meaningful analysis. Subjects in Arm CBD received 400 mg or 800mg of Cannabidiol in each of the three test sessions
All-Cause Mortality
	Control		CBD Group
	Affected / at Risk (%)		Affected / at Risk (%)
Total	--/--		--/--
Serious Adverse Events
	Control		CBD Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/3 (0.00%)		0/6 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Control		CBD Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/3 (100.00%)		4/6 (66.67%)
Gastrointestinal disorders
Diarrhea †	1/3 (33.33%)	3	1/6 (16.67%)	1
Dry Mouth †	2/3 (66.67%)	2	0/6 (0.00%)	0
Increased Appetite †	0/3 (0.00%)	0	1/6 (16.67%)	1
Stomach/abdominal discomfort †	1/3 (33.33%)	1	1/6 (16.67%)	1
General disorders
Increased Thirst †	1/3 (33.33%)	1	0/6 (0.00%)	0
Musculoskeletal and connective tissue disorders
Muscke/bone/joint pain †	1/3 (33.33%)	1	0/6 (0.00%)	0
Nervous system disorders
Heavy Eyes †	1/3 (33.33%)	1	0/6 (0.00%)	0
Drowsiness †	3/3 (100.00%)	3	1/6 (16.67%)	1
Feeling down †	0/3 (0.00%)	0	1/6 (16.67%)	1
Feeling irritable †	0/3 (0.00%)	0	1/6 (16.67%)	1
Renal and urinary disorders
Increased urine frequency †	1/3 (33.33%)	1	0/6 (0.00%)	0
Change in urine color †	0/3 (0.00%)	0	1/6 (16.67%)	1
Vascular disorders
Dizziness †	0/3 (0.00%)	0	1/6 (16.67%)	1
† Indicates events were collected by systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

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

There IS 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.

Results Point of Contact

• Name/Title: Yasmin Hurd, PhD
• Organization: Icahn School of Medicine at Mount Sinai
• Phone: 212-824-9314
• EMail: yasmin.hurd@mssm.edu

• Responsible Party: Yasmin Hurd, Hurd,Yasmin, Ph.D.
• ClinicalTrials.gov Identifier: NCT01605539
• Other Study ID Numbers: R21 DA027781(2)
• First Submitted: May 2, 2012
• First Posted: May 25, 2012
• Results First Submitted: September 28, 2015
• Results First Posted: November 28, 2016
• Last Update Posted: November 28, 2016