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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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:
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
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Control CBD 400 Group CBD 800 Group
Hide 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
Arm/Group Title Control CBD Group Total
Hide 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
Hide 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
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)
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control CBD Group
Hide 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)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control CBD Group
Hide 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
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control CBD Group
Hide 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)
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control CBD Group
Hide 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
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control CBD Group
Hide 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
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control CBD Group
Hide 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
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control CBD Group
Hide 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
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control CBD Group
Hide 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
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control CBD Group
Hide 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)
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
Hide 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   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Control CBD Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/3 (0.00%)      0/6 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide 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
[Not Specified]
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
Layout table for Results Point of Contact information
Name/Title: Yasmin Hurd, PhD
Organization: Icahn School of Medicine at Mount Sinai
Phone: 212-824-9314
EMail: yasmin.hurd@mssm.edu
Layout table for additonal information
Responsible Party: Yasmin Hurd, Hurd,Yasmin, Ph.D.
ClinicalTrials.gov Identifier: NCT01605539     History of Changes
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