Trial Outcomes & Findings for Acute and Short-term Effects of Cannabidiol Admin on Cue-induced Craving in Drug-abstinent Heroin Dependent Humans (NCT NCT01605539)
NCT ID: NCT01605539
Last Updated: 2020-08-11
Results Overview
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
COMPLETED
PHASE2
10 participants
VASC: test visits I, II and IV - baseline 1, post cue (PC), baseline 2, post neutral cue (PN)
2020-08-11
Participant Flow
Participant milestones
| Measure |
Control
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
|
CBD 400 Group
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
|
CBD 800 Group
Subjects in Arm CBD 800 will receive 800 mg of Cannabidiol in each of the three test sessions
|
|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
4
|
|
Overall Study
COMPLETED
|
3
|
2
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Acute and Short-term Effects of Cannabidiol Admin on Cue-induced Craving in Drug-abstinent Heroin Dependent Humans
Baseline characteristics by cohort
| Measure |
Control
n=3 Participants
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
|
CBD Group
n=6 Participants
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
n=9 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=5 Participants
|
6 participants
n=7 Participants
|
9 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: VASC: test visits I, II and IV - baseline 1, post cue (PC), baseline 2, post neutral cue (PN)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
Outcome measures
| Measure |
Control
n=3 Participants
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
|
CBD Group
n=6 Participants
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
|
|---|---|---|
|
Changes in Cue-Induced In-Clinic Craving (From Baseline to Post-cue or Post-neutral - Via the Visual Analog Scale for Craving (VASC)
Test 1: Baseline to Post Drug Cue
|
2.67 units on a scale
Standard Error 1.45
|
0.83 units on a scale
Standard Error 0.31
|
|
Changes in Cue-Induced In-Clinic Craving (From Baseline to Post-cue or Post-neutral - Via the Visual Analog Scale for Craving (VASC)
Test 1: Baseline to Post Neutral Cue
|
-0.33 units on a scale
Standard Error 0.33
|
-0.17 units on a scale
Standard Error 0.17
|
|
Changes in Cue-Induced In-Clinic Craving (From Baseline to Post-cue or Post-neutral - Via the Visual Analog Scale for Craving (VASC)
Test 2: Baseline to Post Drug Cue
|
0.670 units on a scale
Standard Error 0.33
|
0.67 units on a scale
Standard Error 0.71
|
|
Changes in Cue-Induced In-Clinic Craving (From Baseline to Post-cue or Post-neutral - Via the Visual Analog Scale for Craving (VASC)
Test 2: Baseline to Post Neutral Cue
|
-0.33 units on a scale
Standard Error 0.67
|
-0.67 units on a scale
Standard Error 0.71
|
|
Changes in Cue-Induced In-Clinic Craving (From Baseline to Post-cue or Post-neutral - Via the Visual Analog Scale for Craving (VASC)
Test 4: Baseline to Post Drug Cue
|
0.33 units on a scale
Standard Error 0.33
|
0.33 units on a scale
Standard Error 0.21
|
|
Changes in Cue-Induced In-Clinic Craving (From Baseline to Post-cue or Post-neutral - Via the Visual Analog Scale for Craving (VASC)
Test 4: Baseline to Post Neutral Cue
|
1.00 units on a scale
Standard Error 0.58
|
-0.50 units on a scale
Standard Error 0.22
|
PRIMARY outcome
Timeframe: 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 IVSubjects 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.
Outcome measures
| Measure |
Control
n=3 Participants
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
|
CBD Group
n=6 Participants
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
|
|---|---|---|
|
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)
Test 1: Change from pre-dose to 6 hrs post-dose
|
-3.67 units on a scale
Standard Error 2.73
|
-0.33 units on a scale
Standard Error 3.57
|
|
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)
Test 2: Change from pre-dose to 6 hrs post-dose
|
-5.33 units on a scale
Standard Error 15.43
|
-6.17 units on a scale
Standard Error 1.11
|
|
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)
Change from Test 1 (pre-dose) to Test 4 (pre-cue)
|
-4.33 units on a scale
Standard Error 7.69
|
-16.33 units on a scale
Standard Error 3.97
|
SECONDARY outcome
Timeframe: Test sessions 1,2,and 4: baseline 1, post cue (PC), baseline 2, post neutral cue (PN)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.
Outcome measures
| Measure |
Control
n=3 Participants
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
|
CBD Group
n=6 Participants
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
|
|---|---|---|
|
Vital Signs - Blood Pressure
Systolic BP change (mmHG): test 1, baseline to PC
|
8.33 mmHg
Standard Error 3.76
|
4.5 mmHg
Standard Error 3.66
|
|
Vital Signs - Blood Pressure
Systolic BP change (mmHG): test 1, baseline to PN
|
-0.33 mmHg
Standard Error 1.20
|
0.17 mmHg
Standard Error 3.60
|
|
Vital Signs - Blood Pressure
Systolic BP change (mmHG): Test 2, baseline to PC
|
-8.67 mmHg
Standard Error 5.17
|
8.5 mmHg
Standard Error 5.37
|
|
Vital Signs - Blood Pressure
Systolic BP change (mmHG): test 2, baseline to PN
|
5.00 mmHg
Standard Error 3.79
|
4.83 mmHg
Standard Error 3.78
|
|
Vital Signs - Blood Pressure
Systolic BP change (mmHG): Test 4, baseline to PC
|
1.00 mmHg
Standard Error 2.52
|
-6.33 mmHg
Standard Error 4.65
|
|
Vital Signs - Blood Pressure
Systolic BP change (mmHG): test 4, baseline to PN
|
-11.67 mmHg
Standard Error 4.06
|
9.67 mmHg
Standard Error 6.23
|
|
Vital Signs - Blood Pressure
Diastolic BP change (mmHG): test 1, baseline to PC
|
6.33 mmHg
Standard Error 1.33
|
5.33 mmHg
Standard Error 2.63
|
|
Vital Signs - Blood Pressure
Diastolic BP change (mmHG): test 1 baseline to PN
|
-0.33 mmHg
Standard Error 2.19
|
1.5 mmHg
Standard Error 2.51
|
|
Vital Signs - Blood Pressure
Diastolic BP change (mmHG): test 2 baseline to PC
|
-4 mmHg
Standard Error 2.65
|
1.83 mmHg
Standard Error 3.33
|
|
Vital Signs - Blood Pressure
Diastolic BP change (mmHG): test 2 baseline to PN
|
3.67 mmHg
Standard Error 3.93
|
0.83 mmHg
Standard Error 2.20
|
|
Vital Signs - Blood Pressure
Diastolic BP change (mmHG): test 4 baseline to PC
|
-0.33 mmHg
Standard Error 1.45
|
0.67 mmHg
Standard Error 3.34
|
|
Vital Signs - Blood Pressure
Diastolic BP change (mmHG): test 4 baseline to PN
|
-3.67 mmHg
Standard Error 4.91
|
-1.33 mmHg
Standard Error 4.62
|
SECONDARY outcome
Timeframe: Test visit I, II and IV: baseline 1, post cue (PC), baseline 2, post neutral cue (PN)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.
Outcome measures
| Measure |
Control
n=3 Participants
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
|
CBD Group
n=6 Participants
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
|
|---|---|---|
|
Visual Analog Scale for Anxiety (VASA)
Test 2: Baseline to Post Drug Cue
|
1.33 units on a scale
Standard Error 1.20
|
-0.50 units on a scale
Standard Error 0.34
|
|
Visual Analog Scale for Anxiety (VASA)
Test 4: Baseline to Post Neutral Cue
|
-0.67 units on a scale
Standard Error 0.67
|
-0.33 units on a scale
Standard Error 0.21
|
|
Visual Analog Scale for Anxiety (VASA)
Test 1: Baseline to Post Drug Cue
|
2.00 units on a scale
Standard Error 1.15
|
0.00 units on a scale
Standard Error 0.26
|
|
Visual Analog Scale for Anxiety (VASA)
Test 1: Baseline to Post Neutral Cue
|
0.33 units on a scale
Standard Error 0.33
|
-0.33 units on a scale
Standard Error 0.21
|
|
Visual Analog Scale for Anxiety (VASA)
Test 2: Baseline to Post Neutral Cue
|
-0.67 units on a scale
Standard Error 0.88
|
-0.50 units on a scale
Standard Error 0.34
|
|
Visual Analog Scale for Anxiety (VASA)
Test 4: Baseline to Post Drug Cue
|
0.00 units on a scale
Standard Error 0.00
|
0.00 units on a scale
Standard Error 0.00
|
SECONDARY outcome
Timeframe: Test session 1, 2, and 4: baseline 1, post cue (PC), baseline 2, post neutral cue (PN)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.
Outcome measures
| Measure |
Control
n=3 Participants
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
|
CBD Group
n=6 Participants
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
|
|---|---|---|
|
The Positive and Negative Affect Schedule (PANAS) - Positive Affect Schedule (PAS) Data
Test 1: Baseline to Post Drug Cue
|
1.33 units on a scale
Standard Error 2.40
|
-0.50 units on a scale
Standard Error 1.88
|
|
The Positive and Negative Affect Schedule (PANAS) - Positive Affect Schedule (PAS) Data
Test 1: Baseline to Post-Neutral Cue
|
1.33 units on a scale
Standard Error 1.20
|
-1.83 units on a scale
Standard Error 0.83
|
|
The Positive and Negative Affect Schedule (PANAS) - Positive Affect Schedule (PAS) Data
Test 2: Baseline to Post Drug Cue
|
-4.00 units on a scale
Standard Error 1.73
|
-1.00 units on a scale
Standard Error 1.03
|
|
The Positive and Negative Affect Schedule (PANAS) - Positive Affect Schedule (PAS) Data
Test 2: Baseline to Post Neutral Cue
|
-4.67 units on a scale
Standard Error 2.40
|
0.17 units on a scale
Standard Error 1.01
|
|
The Positive and Negative Affect Schedule (PANAS) - Positive Affect Schedule (PAS) Data
Test 4: Baseline to Post Drug Cue
|
-3.50 units on a scale
Standard Error 3.50
|
-1.33 units on a scale
Standard Error 0.61
|
|
The Positive and Negative Affect Schedule (PANAS) - Positive Affect Schedule (PAS) Data
Test 4: Baseline to Post Neutral Cue
|
2.50 units on a scale
Standard Error 2.50
|
0.67 units on a scale
Standard Error 0.49
|
SECONDARY outcome
Timeframe: Test session 1, 2, and 4: baseline 1, post cue (PC), baseline 2, post neutral cue (PN)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.
Outcome measures
| Measure |
Control
n=3 Participants
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
|
CBD Group
n=6 Participants
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
|
|---|---|---|
|
The Positive and Negative Affect Schedule (PANAS) - Negative Affect Schedule (NAS) Data
Test 1: Baseline to Post Neutral Cue
|
1.33 units on a scale
Standard Error 0.88
|
-1.50 units on a scale
Standard Error 0.67
|
|
The Positive and Negative Affect Schedule (PANAS) - Negative Affect Schedule (NAS) Data
Test 2: Baseline to Post Drug Cue
|
4.00 units on a scale
Standard Error 7.55
|
0.00 units on a scale
Standard Error 1.29
|
|
The Positive and Negative Affect Schedule (PANAS) - Negative Affect Schedule (NAS) Data
Test 2: Baseline to Post Neutral Cue
|
-0.33 units on a scale
Standard Error 3.28
|
0.17 units on a scale
Standard Error 0.17
|
|
The Positive and Negative Affect Schedule (PANAS) - Negative Affect Schedule (NAS) Data
Test 4: Baseline to Post Drug Cue
|
-1.50 units on a scale
Standard Error 0.50
|
0.33 units on a scale
Standard Error 0.21
|
|
The Positive and Negative Affect Schedule (PANAS) - Negative Affect Schedule (NAS) Data
Test 4: Baseline to Post Neutral Cue
|
-7.00 units on a scale
Standard Error 8.00
|
-0.67 units on a scale
Standard Error 0.67
|
|
The Positive and Negative Affect Schedule (PANAS) - Negative Affect Schedule (NAS) Data
Test 1: Baseline to Post Drug Cue
|
4.00 units on a scale
Standard Error 3.51
|
0.50 units on a scale
Standard Error 0.92
|
SECONDARY outcome
Timeframe: Test sessions 1,2,and 4: baseline 1, post cue (PC), baseline 2, post neutral cue (PN)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.
Outcome measures
| Measure |
Control
n=3 Participants
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
|
CBD Group
n=6 Participants
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
|
|---|---|---|
|
Vital Signs - Heart Rate
Heart rate change (bpm): test 1 baseline to PC
|
-2.33 beats per minute
Standard Error 1.67
|
4.00 beats per minute
Standard Error 2.21
|
|
Vital Signs - Heart Rate
Heart rate change (bpm): test 1 baseline to PN
|
-6 beats per minute
Standard Error 7.55
|
2.5 beats per minute
Standard Error 2.72
|
|
Vital Signs - Heart Rate
Heart rate change (bpm): test 2 baseline to PC
|
-8 beats per minute
Standard Error 3.06
|
-6.5 beats per minute
Standard Error 3.15
|
|
Vital Signs - Heart Rate
Heart rate change (bpm): test 2 baseline to PN
|
-1.33 beats per minute
Standard Error 0.67
|
-3.33 beats per minute
Standard Error 2.5
|
|
Vital Signs - Heart Rate
Heart rate change (bpm): test 4 baseline to PC
|
0 beats per minute
Standard Error 1.15
|
-3.33 beats per minute
Standard Error 1.78
|
|
Vital Signs - Heart Rate
Heart rate change (bpm): test 4 baseline to PN
|
-1.67 beats per minute
Standard Error 2.67
|
-2.17 beats per minute
Standard Error 2.5
|
SECONDARY outcome
Timeframe: Test sessions 1,2,and 4: baseline 1, post cue (PC), baseline 2, post neutral cue (PN)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.
Outcome measures
| Measure |
Control
n=3 Participants
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
|
CBD Group
n=6 Participants
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
|
|---|---|---|
|
Vital Signs - Respiratory Rate
Respiratory rate (bpm): test 1 baseline to PC
|
0 breaths per minute
Standard Error 0
|
0 breaths per minute
Standard Error 0.52
|
|
Vital Signs - Respiratory Rate
Respiratory rate (bpm): test 1 baseline to PN
|
0 breaths per minute
Standard Error 0
|
0 breaths per minute
Standard Error 0.52
|
|
Vital Signs - Respiratory Rate
Respiratory rate (bpm): test 2 baseline to PC
|
-0.67 breaths per minute
Standard Error 0.67
|
0 breaths per minute
Standard Error 0.52
|
|
Vital Signs - Respiratory Rate
Respiratory rate (bpm): test 2 baseline to PN
|
0 breaths per minute
Standard Error 0
|
-1 breaths per minute
Standard Error 0.45
|
|
Vital Signs - Respiratory Rate
Respiratory rate (bpm): test 4 baseline to PC
|
-0.67 breaths per minute
Standard Error 0.67
|
-0.67 breaths per minute
Standard Error 0.42
|
|
Vital Signs - Respiratory Rate
Respiratory rate (bpm): test 4 baseline to PN
|
-0.67 breaths per minute
Standard Error 0.67
|
0.33 breaths per minute
Standard Error 0.33
|
SECONDARY outcome
Timeframe: Test sessions 1,2,and 4: baseline 1, post cue (PC), baseline 2, post neutral cue (PN)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.
Outcome measures
| Measure |
Control
n=3 Participants
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
|
CBD Group
n=6 Participants
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
|
|---|---|---|
|
Vital Signs - Temperature
Temperature change (F): test 1 baseline to PC
|
0.03 degrees F
Standard Error 0.03
|
-3.35 degrees F
Standard Error 3.33
|
|
Vital Signs - Temperature
Temperature change (F): test 1 baseline to PN
|
0.43 degrees F
Standard Error 0.75
|
0.03 degrees F
Standard Error 0.13
|
|
Vital Signs - Temperature
Temperature change (F): test 2 baseline to PC
|
0.0 degrees F
Standard Error 0.1
|
0.05 degrees F
Standard Error 0.10
|
|
Vital Signs - Temperature
Temperature change (F): test 2 baseline to PN
|
0 degrees F
Standard Error 0.2
|
0.02 degrees F
Standard Error 0.19
|
|
Vital Signs - Temperature
Temperature change (F): test 4 baseline to PC
|
0.3 degrees F
Standard Error 0.31
|
0.18 degrees F
Standard Error 0.08
|
|
Vital Signs - Temperature
Temperature change (F): test 4 baseline to PN
|
0.13 degrees F
Standard Error 0.28
|
-0.17 degrees F
Standard Error 0.09
|
Adverse Events
Control
CBD Group
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Control
n=3 participants at risk
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
|
CBD Group
n=6 participants at risk
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
|
|---|---|---|
|
Nervous system disorders
Heavy Eyes
|
33.3%
1/3 • Number of events 1
Adverse events were collected by using SAFTEE (Systematic Assessment for Treatment Emergent Events)
|
0.00%
0/6
Adverse events were collected by using SAFTEE (Systematic Assessment for Treatment Emergent Events)
|
|
Gastrointestinal disorders
Dry Mouth
|
66.7%
2/3 • Number of events 2
Adverse events were collected by using SAFTEE (Systematic Assessment for Treatment Emergent Events)
|
0.00%
0/6
Adverse events were collected by using SAFTEE (Systematic Assessment for Treatment Emergent Events)
|
|
Gastrointestinal disorders
Increased Appetite
|
0.00%
0/3
Adverse events were collected by using SAFTEE (Systematic Assessment for Treatment Emergent Events)
|
16.7%
1/6 • Number of events 1
Adverse events were collected by using SAFTEE (Systematic Assessment for Treatment Emergent Events)
|
|
Gastrointestinal disorders
Stomach/abdominal discomfort
|
33.3%
1/3 • Number of events 1
Adverse events were collected by using SAFTEE (Systematic Assessment for Treatment Emergent Events)
|
16.7%
1/6 • Number of events 1
Adverse events were collected by using SAFTEE (Systematic Assessment for Treatment Emergent Events)
|
|
General disorders
Increased Thirst
|
33.3%
1/3 • Number of events 1
Adverse events were collected by using SAFTEE (Systematic Assessment for Treatment Emergent Events)
|
0.00%
0/6
Adverse events were collected by using SAFTEE (Systematic Assessment for Treatment Emergent Events)
|
|
Nervous system disorders
Drowsiness
|
100.0%
3/3 • Number of events 3
Adverse events were collected by using SAFTEE (Systematic Assessment for Treatment Emergent Events)
|
16.7%
1/6 • Number of events 1
Adverse events were collected by using SAFTEE (Systematic Assessment for Treatment Emergent Events)
|
|
Nervous system disorders
Feeling down
|
0.00%
0/3
Adverse events were collected by using SAFTEE (Systematic Assessment for Treatment Emergent Events)
|
16.7%
1/6 • Number of events 1
Adverse events were collected by using SAFTEE (Systematic Assessment for Treatment Emergent Events)
|
|
Nervous system disorders
Feeling irritable
|
0.00%
0/3
Adverse events were collected by using SAFTEE (Systematic Assessment for Treatment Emergent Events)
|
16.7%
1/6 • Number of events 1
Adverse events were collected by using SAFTEE (Systematic Assessment for Treatment Emergent Events)
|
|
Musculoskeletal and connective tissue disorders
Muscke/bone/joint pain
|
33.3%
1/3 • Number of events 1
Adverse events were collected by using SAFTEE (Systematic Assessment for Treatment Emergent Events)
|
0.00%
0/6
Adverse events were collected by using SAFTEE (Systematic Assessment for Treatment Emergent Events)
|
|
Renal and urinary disorders
Increased urine frequency
|
33.3%
1/3 • Number of events 1
Adverse events were collected by using SAFTEE (Systematic Assessment for Treatment Emergent Events)
|
0.00%
0/6
Adverse events were collected by using SAFTEE (Systematic Assessment for Treatment Emergent Events)
|
|
Renal and urinary disorders
Change in urine color
|
0.00%
0/3
Adverse events were collected by using SAFTEE (Systematic Assessment for Treatment Emergent Events)
|
16.7%
1/6 • Number of events 1
Adverse events were collected by using SAFTEE (Systematic Assessment for Treatment Emergent Events)
|
|
Gastrointestinal disorders
Diarrhea
|
33.3%
1/3 • Number of events 3
Adverse events were collected by using SAFTEE (Systematic Assessment for Treatment Emergent Events)
|
16.7%
1/6 • Number of events 1
Adverse events were collected by using SAFTEE (Systematic Assessment for Treatment Emergent Events)
|
|
Vascular disorders
Dizziness
|
0.00%
0/3
Adverse events were collected by using SAFTEE (Systematic Assessment for Treatment Emergent Events)
|
16.7%
1/6 • Number of events 1
Adverse events were collected by using SAFTEE (Systematic Assessment for Treatment Emergent Events)
|
Additional Information
Yasmin Hurd, PhD
Icahn School of Medicine at Mount Sinai
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60