Trial Outcomes & Findings for Acute and Short-term Effects of CBD on Cue-induced Craving in Drug-abstinent Heroin-dependent Humans (NCT NCT02539823)
NCT ID: NCT02539823
Last Updated: 2022-09-01
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 in the clinic will be measured. Note, cue sessions occur consecutively in the same test day. In this way, changes in craving from baseline (pre-cue to post-cue within each test day), as well as changes in cue-induced craving over the short-term (test day 1 through test day 4 a week later) will be monitored and measured. VASC scale ranges from 0 for "Not Craving at All" to 10 for "Extremely Craving."
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
45 participants
Primary outcome timeframe
VASC: test day I, II and IV - at arrival, baseline for cue 1 and 2, post-cue 1 and 2, before discharge (approximately 2.5 hours from session start on average); test day III: at arrival and discharge (approx. 2.5 hours from session start on average)
Results posted on
2022-09-01
Participant Flow
Participant milestones
| Measure |
Control
Subjects will receive a solution that resemble the Cannabidiol solution but do not have have its properties
Control (placebo): Subjects will receive a harmless, inactive solution to compare and validate the results of the other arms of the study
|
CBD 400mg
Subjects will receive 400mg of cannabidiol
CBD 400 mg: Subjects in Arm CBD 400 mg will receive 400mg of Cannabidiol in each of the three test sessions
|
CBD 800mg
Subjects will receive 800 mg of cannabidiol
CBD 800 mg: Subjects in Arm CBD 800 mg will receive 800mg of Cannabidiol in each of the three test sessions
|
|---|---|---|---|
|
Overall Study
STARTED
|
15
|
14
|
13
|
|
Overall Study
COMPLETED
|
15
|
14
|
13
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Acute and Short-term Effects of CBD on Cue-induced Craving in Drug-abstinent Heroin-dependent Humans
Baseline characteristics by cohort
| Measure |
Control
n=15 Participants
Subjects will receive a solution that resemble the Cannabidiol solution but do not have have its properties
Control (placebo): Subjects will receive a harmless, inactive solution to compare and validate the results of the other arms of the study
|
CBD 400mg
n=14 Participants
Subjects will receive 400mg of cannabidiol
CBD 400 mg: Subjects in Arm CBD 400 mg will receive 400mg of Cannabidiol in each of the three test sessions
|
CBD 800mg
n=13 Participants
Subjects will receive 800 mg of cannabidiol
CBD 800 mg: Subjects in Arm CBD 800 mg will receive 800mg of Cannabidiol in each of the three test sessions
|
Total
n=42 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
47.3 years
STANDARD_DEVIATION 8.0 • n=5 Participants
|
51.9 years
STANDARD_DEVIATION 7.9 • n=7 Participants
|
50.5 years
STANDARD_DEVIATION 11.6 • n=5 Participants
|
49.8 years
STANDARD_DEVIATION 9.2 • n=4 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
35 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black
|
9 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=5 Participants
|
14 participants
n=7 Participants
|
13 participants
n=5 Participants
|
42 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: VASC: test day I, II and IV - at arrival, baseline for cue 1 and 2, post-cue 1 and 2, before discharge (approximately 2.5 hours from session start on average); test day III: at arrival and discharge (approx. 2.5 hours from session start on average)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 in the clinic will be measured. Note, cue sessions occur consecutively in the same test day. In this way, changes in craving from baseline (pre-cue to post-cue within each test day), as well as changes in cue-induced craving over the short-term (test day 1 through test day 4 a week later) will be monitored and measured. VASC scale ranges from 0 for "Not Craving at All" to 10 for "Extremely Craving."
Outcome measures
| Measure |
Control
n=15 Participants
Subjects will receive a solution that resemble the Cannabidiol solution but do not have have its properties
Control (placebo): Subjects will receive a harmless, inactive solution to compare and validate the results of the other arms of the study
|
CBD 400mg
n=14 Participants
Subjects will receive 400mg of cannabidiol
CBD 400 mg: Subjects in Arm CBD 400 mg will receive 400mg of Cannabidiol in each of the three test sessions
|
CBD 800mg
n=13 Participants
Subjects will receive 800 mg of cannabidiol
CBD 800 mg: Subjects in Arm CBD 800 mg will receive 800mg of Cannabidiol in each of the three test sessions
|
|---|---|---|---|
|
Changes in Cue-Induced In-Clinic Craving (From Baseline to Post-cue (30 Minutes), and From Test Day 1 Through Test Day 4 (1 Week)) - Via the Visual Analog Scale for Craving (VASC)
Second Post Cue Session 4
|
1.20 units on a scale
Standard Error 1.781
|
.79 units on a scale
Standard Error 1.188
|
.75 units on a scale
Standard Error 1.422
|
|
Changes in Cue-Induced In-Clinic Craving (From Baseline to Post-cue (30 Minutes), and From Test Day 1 Through Test Day 4 (1 Week)) - Via the Visual Analog Scale for Craving (VASC)
First Baseline (before cue video) Session 1
|
1.40 units on a scale
Standard Error 1.765
|
1.64 units on a scale
Standard Error 1.946
|
2.31 units on a scale
Standard Error 2.057
|
|
Changes in Cue-Induced In-Clinic Craving (From Baseline to Post-cue (30 Minutes), and From Test Day 1 Through Test Day 4 (1 Week)) - Via the Visual Analog Scale for Craving (VASC)
First Baseline (before cue video) Session 2
|
1.33 units on a scale
Standard Error 1.33
|
1.07 units on a scale
Standard Error 1.141
|
1.46 units on a scale
Standard Error 2.106
|
|
Changes in Cue-Induced In-Clinic Craving (From Baseline to Post-cue (30 Minutes), and From Test Day 1 Through Test Day 4 (1 Week)) - Via the Visual Analog Scale for Craving (VASC)
First Baseline (before cue video) Session 4
|
.53 units on a scale
Standard Error .53
|
.79 units on a scale
Standard Error 1.051
|
1.58 units on a scale
Standard Error 2.429
|
|
Changes in Cue-Induced In-Clinic Craving (From Baseline to Post-cue (30 Minutes), and From Test Day 1 Through Test Day 4 (1 Week)) - Via the Visual Analog Scale for Craving (VASC)
First Post Cue Session 1
|
2.53 units on a scale
Standard Error 3.091
|
2.21 units on a scale
Standard Error 1.929
|
2.69 units on a scale
Standard Error 1.932
|
|
Changes in Cue-Induced In-Clinic Craving (From Baseline to Post-cue (30 Minutes), and From Test Day 1 Through Test Day 4 (1 Week)) - Via the Visual Analog Scale for Craving (VASC)
First Post Cue Session 2
|
2.00 units on a scale
Standard Error 2.646
|
1.36 units on a scale
Standard Error 1.336
|
1.85 units on a scale
Standard Error 2.512
|
|
Changes in Cue-Induced In-Clinic Craving (From Baseline to Post-cue (30 Minutes), and From Test Day 1 Through Test Day 4 (1 Week)) - Via the Visual Analog Scale for Craving (VASC)
First Post Cue Session 4
|
1.27 units on a scale
Standard Error 1.710
|
1.07 units on a scale
Standard Error 1.141
|
1.67 units on a scale
Standard Error 2.498
|
|
Changes in Cue-Induced In-Clinic Craving (From Baseline to Post-cue (30 Minutes), and From Test Day 1 Through Test Day 4 (1 Week)) - Via the Visual Analog Scale for Craving (VASC)
Second Base Line (before cue video) Session 1
|
1.47 units on a scale
Standard Error 2.326
|
1.43 units on a scale
Standard Error 1.950
|
1.77 units on a scale
Standard Error 1.878
|
|
Changes in Cue-Induced In-Clinic Craving (From Baseline to Post-cue (30 Minutes), and From Test Day 1 Through Test Day 4 (1 Week)) - Via the Visual Analog Scale for Craving (VASC)
Second Base Line (before cue video) Session 2
|
1.00 units on a scale
Standard Error 1.363
|
1.00 units on a scale
Standard Error 1.109
|
1.62 units on a scale
Standard Error 2.022
|
|
Changes in Cue-Induced In-Clinic Craving (From Baseline to Post-cue (30 Minutes), and From Test Day 1 Through Test Day 4 (1 Week)) - Via the Visual Analog Scale for Craving (VASC)
Second Base Line (before cue video) Session 4
|
.60 units on a scale
Standard Error 1.121
|
.79 units on a scale
Standard Error 1.122
|
1.00 units on a scale
Standard Error 1.595
|
|
Changes in Cue-Induced In-Clinic Craving (From Baseline to Post-cue (30 Minutes), and From Test Day 1 Through Test Day 4 (1 Week)) - Via the Visual Analog Scale for Craving (VASC)
Second Post Cue Session 1
|
2.40 units on a scale
Standard Error 2.746
|
1.36 units on a scale
Standard Error 1.598
|
1.69 units on a scale
Standard Error 1.797
|
|
Changes in Cue-Induced In-Clinic Craving (From Baseline to Post-cue (30 Minutes), and From Test Day 1 Through Test Day 4 (1 Week)) - Via the Visual Analog Scale for Craving (VASC)
Second Post Cue Session 2
|
1.87 units on a scale
Standard Error 2.696
|
1.79 units on a scale
Standard Error 1.805
|
1.62 units on a scale
Standard Error 2.219
|
|
Changes in Cue-Induced In-Clinic Craving (From Baseline to Post-cue (30 Minutes), and From Test Day 1 Through Test Day 4 (1 Week)) - Via the Visual Analog Scale for Craving (VASC)
Post Relaxation video Session 1
|
.33 units on a scale
Standard Error .617
|
.93 units on a scale
Standard Error 1.072
|
1.08 units on a scale
Standard Error 1.188
|
|
Changes in Cue-Induced In-Clinic Craving (From Baseline to Post-cue (30 Minutes), and From Test Day 1 Through Test Day 4 (1 Week)) - Via the Visual Analog Scale for Craving (VASC)
Post Relaxation video Session 2
|
.93 units on a scale
Standard Error 1.280
|
.64 units on a scale
Standard Error .842
|
1.00 units on a scale
Standard Error 1.633
|
|
Changes in Cue-Induced In-Clinic Craving (From Baseline to Post-cue (30 Minutes), and From Test Day 1 Through Test Day 4 (1 Week)) - Via the Visual Analog Scale for Craving (VASC)
Post Relaxation video Session 4
|
.33 units on a scale
Standard Error 1.047
|
.64 units on a scale
Standard Error 1.008
|
.58 units on a scale
Standard Error .900
|
PRIMARY outcome
Timeframe: HCQ: once in clinic pre-dose at each test day, and once at home after each test day.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 day 1 through test day 4 (1 week later). Each item is scored on a scale ranging from 1 for "Strongly Disagree" to 7 for "Strongly Agree." Sum of all 14 items are scored and added. Mean scores reported below. Total Score Range: 14 (less cravings) - 98 (more cravings).
Outcome measures
| Measure |
Control
n=15 Participants
Subjects will receive a solution that resemble the Cannabidiol solution but do not have have its properties
Control (placebo): Subjects will receive a harmless, inactive solution to compare and validate the results of the other arms of the study
|
CBD 400mg
n=14 Participants
Subjects will receive 400mg of cannabidiol
CBD 400 mg: Subjects in Arm CBD 400 mg will receive 400mg of Cannabidiol in each of the three test sessions
|
CBD 800mg
n=13 Participants
Subjects will receive 800 mg of cannabidiol
CBD 800 mg: Subjects in Arm CBD 800 mg will receive 800mg of Cannabidiol in each of the three test sessions
|
|---|---|---|---|
|
Changes in Out-of-Clinic Craving (From Pre-dose to Approximately 4-6 Hours Post-dose; and From Test Day 1 to Test Day 4 or 1 Week) - Via the Heroin Craving Questionnaire (HCQ)
Session 1: Pre Drug/Placebo (Baseline)
|
60.13 units on a scale
Interval 56.36 to 63.91
|
59.33 units on a scale
Interval 53.87 to 64.8
|
59.75 units on a scale
Interval 54.72 to 64.78
|
|
Changes in Out-of-Clinic Craving (From Pre-dose to Approximately 4-6 Hours Post-dose; and From Test Day 1 to Test Day 4 or 1 Week) - Via the Heroin Craving Questionnaire (HCQ)
Session 1: Post (At Home)
|
53.20 units on a scale
Interval 47.86 to 58.54
|
50.00 units on a scale
Interval 43.23 to 56.77
|
53.42 units on a scale
Interval 46.23 to 60.6
|
|
Changes in Out-of-Clinic Craving (From Pre-dose to Approximately 4-6 Hours Post-dose; and From Test Day 1 to Test Day 4 or 1 Week) - Via the Heroin Craving Questionnaire (HCQ)
Session 2: Pre Drug/Placebo (Day 2 Baseline)
|
53.40 units on a scale
Interval 49.88 to 56.92
|
52.00 units on a scale
Interval 45.33 to 58.67
|
51.17 units on a scale
Interval 45.13 to 57.2
|
|
Changes in Out-of-Clinic Craving (From Pre-dose to Approximately 4-6 Hours Post-dose; and From Test Day 1 to Test Day 4 or 1 Week) - Via the Heroin Craving Questionnaire (HCQ)
Session 2 Post (At Home)
|
54.80 units on a scale
Interval 49.7 to 59.9
|
49.47 units on a scale
Interval 42.32 to 56.61
|
54.92 units on a scale
Interval 45.5 to 64.33
|
|
Changes in Out-of-Clinic Craving (From Pre-dose to Approximately 4-6 Hours Post-dose; and From Test Day 1 to Test Day 4 or 1 Week) - Via the Heroin Craving Questionnaire (HCQ)
Session 3: Pre Drug/Placebo (Day 3 Baseline)
|
52.67 units on a scale
Interval 46.84 to 58.49
|
50.87 units on a scale
Interval 43.65 to 58.08
|
53.92 units on a scale
Interval 45.79 to 62.04
|
|
Changes in Out-of-Clinic Craving (From Pre-dose to Approximately 4-6 Hours Post-dose; and From Test Day 1 to Test Day 4 or 1 Week) - Via the Heroin Craving Questionnaire (HCQ)
Session 3 Post (At Home)
|
52.21 units on a scale
Interval 48.92 to 55.51
|
50.20 units on a scale
Interval 43.79 to 56.61
|
55.40 units on a scale
Interval 47.88 to 63.12
|
|
Changes in Out-of-Clinic Craving (From Pre-dose to Approximately 4-6 Hours Post-dose; and From Test Day 1 to Test Day 4 or 1 Week) - Via the Heroin Craving Questionnaire (HCQ)
Session 4: Drug/Placebo (Day 4 Baseline)
|
53.53 units on a scale
Interval 50.11 to 56.95
|
49.67 units on a scale
Interval 42.83 to 56.5
|
52.09 units on a scale
Interval 41.81 to 62.37
|
SECONDARY outcome
Timeframe: Pre-placebo/drug, -60 min pre-cue, -40 min pre-cue, -20 min pre-cue, cue (time 0), 15 min post-cue, 35 min post-cue, 50 min post-cue, 65 min post-cue, 85 min post-cueBlood pressure (in mmHg), heart rate (in beats/min), temperature (in degrees Fahrenheit), respiratory rate (in breaths/min), and O2 saturation and pain will be monitored throughout the time course of the study and changes from baseline will be studied across the various time points. Note, cue sessions occur consecutively in the same test day. Results reported below are responses from baseline following exposure to neutral and heroin-associated cues in Session 1 in subjects with CBD or placebo administration.
Outcome measures
| Measure |
Control
n=15 Participants
Subjects will receive a solution that resemble the Cannabidiol solution but do not have have its properties
Control (placebo): Subjects will receive a harmless, inactive solution to compare and validate the results of the other arms of the study
|
CBD 400mg
n=14 Participants
Subjects will receive 400mg of cannabidiol
CBD 400 mg: Subjects in Arm CBD 400 mg will receive 400mg of Cannabidiol in each of the three test sessions
|
CBD 800mg
n=13 Participants
Subjects will receive 800 mg of cannabidiol
CBD 800 mg: Subjects in Arm CBD 800 mg will receive 800mg of Cannabidiol in each of the three test sessions
|
|---|---|---|---|
|
Vital Signs
Session 1 baseline pre-neutral cue
|
76.75 beats per minute
Standard Deviation 11.889
|
76.30 beats per minute
Standard Deviation 11.295
|
78.00 beats per minute
Standard Deviation 10.970
|
|
Vital Signs
Session 1 -60 min pre-neutral cue
|
76.25 beats per minute
Standard Deviation 10.899
|
75.80 beats per minute
Standard Deviation 10.789
|
77.57 beats per minute
Standard Deviation 10.390
|
|
Vital Signs
Session 1 -40 min pre-neutral cue
|
74.13 beats per minute
Standard Deviation 13.943
|
76.10 beats per minute
Standard Deviation 12.662
|
74.14 beats per minute
Standard Deviation 10.270
|
|
Vital Signs
Session 1 -20 min pre-neutral cue
|
73.63 beats per minute
Standard Deviation 13.223
|
75.10 beats per minute
Standard Deviation 11.638
|
73.29 beats per minute
Standard Deviation 9.844
|
|
Vital Signs
Session 1 cue (time 0) pre-neutral cue
|
73.75 beats per minute
Standard Deviation 14.119
|
72.80 beats per minute
Standard Deviation 12.874
|
74.43 beats per minute
Standard Deviation 11.312
|
|
Vital Signs
Session 1 15 min post-neutral cue
|
71.63 beats per minute
Standard Deviation 15.747
|
74.70 beats per minute
Standard Deviation 11.136
|
73.57 beats per minute
Standard Deviation 11.178
|
|
Vital Signs
Session 1 35 min post-neutral cue
|
71.00 beats per minute
Standard Deviation 15.657
|
72.60 beats per minute
Standard Deviation 10.511
|
71.43 beats per minute
Standard Deviation 8.284
|
|
Vital Signs
Session 1 50 min post-neutral cue
|
70.25 beats per minute
Standard Deviation 14.230
|
70.40 beats per minute
Standard Deviation 9.755
|
68.57 beats per minute
Standard Deviation 7.044
|
|
Vital Signs
Session 1 65 min post-neutral cue
|
69.38 beats per minute
Standard Deviation 12.883
|
68.80 beats per minute
Standard Deviation 8.954
|
66.71 beats per minute
Standard Deviation 6.849
|
|
Vital Signs
Session 1 85 min post-neutral cue
|
68.75 beats per minute
Standard Deviation 13.328
|
69.70 beats per minute
Standard Deviation 10.935
|
71.14 beats per minute
Standard Deviation 10.090
|
|
Vital Signs
Session 1 baseline pre-drug cue
|
76.83 beats per minute
Standard Deviation 10.187
|
71.00 beats per minute
Standard Deviation 12.166
|
74.40 beats per minute
Standard Deviation 5.413
|
|
Vital Signs
Session 1 -60 min pre-drug cue
|
77.50 beats per minute
Standard Deviation 11.005
|
71.40 beats per minute
Standard Deviation 11.845
|
73.80 beats per minute
Standard Deviation 6.535
|
|
Vital Signs
Session 1 -40 min pre-drug cue
|
76.50 beats per minute
Standard Deviation 9.955
|
70.20 beats per minute
Standard Deviation 9.935
|
68.80 beats per minute
Standard Deviation 4.324
|
|
Vital Signs
Session 1 -20 min pre-drug cue
|
74.00 beats per minute
Standard Deviation 9.445
|
72.00 beats per minute
Standard Deviation 9.695
|
69.20 beats per minute
Standard Deviation 4.764
|
|
Vital Signs
Session 1 cue (time 0) pre-drug cue
|
72.67 beats per minute
Standard Deviation 10.013
|
70.00 beats per minute
Standard Deviation 9.592
|
68.00 beats per minute
Standard Deviation 4.359
|
|
Vital Signs
Session 1 15 min post-drug cue
|
74.50 beats per minute
Standard Deviation 10.521
|
69.00 beats per minute
Standard Deviation 8.718
|
67.20 beats per minute
Standard Deviation 2.775
|
|
Vital Signs
Session 1 35 min post-drug cue
|
74.50 beats per minute
Standard Deviation 11.879
|
66.80 beats per minute
Standard Deviation 10.085
|
66.00 beats per minute
Standard Deviation 3.391
|
|
Vital Signs
Session 1 50 min post-drug cue
|
77.33 beats per minute
Standard Deviation 7.607
|
69.80 beats per minute
Standard Deviation 10.569
|
67.40 beats per minute
Standard Deviation 2.881
|
|
Vital Signs
Session 1 65 min post-drug cue
|
76.00 beats per minute
Standard Deviation 10.770
|
66.40 beats per minute
Standard Deviation 9.423
|
67.40 beats per minute
Standard Deviation 2.881
|
|
Vital Signs
Session 1 85 min post-drug cue
|
73.67 beats per minute
Standard Deviation 10.875
|
68.00 beats per minute
Standard Deviation 7.842
|
65.20 beats per minute
Standard Deviation 3.114
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 2 times: once at pre-screening and once at test day 4, within 2 weeks of each other.Digit Span Backwards (DSB) is a memory task consisting of a span of digits recalled in reverse order. Participants are read a series of digits (e.g., 4,7,1) and must immediately repeat them back in reverse order (e.g., 1,7,4). Mean correct response times (hits) are reported below in milliseconds. Shorter response times indicate better participant outcomes. Digit Symbol Substitution Task (DSST) is a neuropsychological test consisting of digit-symbol pairs.The goal is to complete as many correct patterns as possible in 3 mins. Mean response times reported below in ms, with shorter times indicating better outcomes.
Outcome measures
| Measure |
Control
n=15 Participants
Subjects will receive a solution that resemble the Cannabidiol solution but do not have have its properties
Control (placebo): Subjects will receive a harmless, inactive solution to compare and validate the results of the other arms of the study
|
CBD 400mg
n=14 Participants
Subjects will receive 400mg of cannabidiol
CBD 400 mg: Subjects in Arm CBD 400 mg will receive 400mg of Cannabidiol in each of the three test sessions
|
CBD 800mg
n=13 Participants
Subjects will receive 800 mg of cannabidiol
CBD 800 mg: Subjects in Arm CBD 800 mg will receive 800mg of Cannabidiol in each of the three test sessions
|
|---|---|---|---|
|
CBD Effects on Cognitive Behavior
Digit Symbol Substitution Test (DSST) - Pre·Screen Response Time (ms)
|
12.99 units on a scale (ms)
Standard Deviation 5.2
|
11.68 units on a scale (ms)
Standard Deviation 11.2
|
15.83 units on a scale (ms)
Standard Deviation 27.0
|
|
CBD Effects on Cognitive Behavior
Digit Symbol Substitution Test (DSST) - Test Day 4 Response Time (ms)
|
11.81 units on a scale (ms)
Standard Deviation 4.2
|
7.09 units on a scale (ms)
Standard Deviation 5.1
|
8.73 units on a scale (ms)
Standard Deviation 4.6
|
|
CBD Effects on Cognitive Behavior
Digit-Span Backwards (DSB) - Pre·Screen Response Time (ms)
|
79.48 units on a scale (ms)
Standard Deviation 80.9
|
76.07 units on a scale (ms)
Standard Deviation 37.4
|
71.6 units on a scale (ms)
Standard Deviation 33.4
|
|
CBD Effects on Cognitive Behavior
Digit-Span Backwards (DSB) - Test Day 4 Response Time (ms)
|
93.35 units on a scale (ms)
Standard Deviation 43.1
|
97.57 units on a scale (ms)
Standard Deviation 59.6
|
92.27 units on a scale (ms)
Standard Deviation 40.8
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Test day I, II and IV: on arrival, baseline for cue sessions 1 and 2, post-cue sessions I and 2 (30 min from baseline), prior to discharge (approximately 2.5 hours from test day start on average); Test day III: on arrival and prior to discharge.Questionnaires will be used to measure subjective responses. Anxiety will be assessed using a visual analog scale for anxiety (VASA). VASA scale ranges from 0 for "Not Anxious at All" to 10 for "Extremely Anxious." Note, cue sessions occur consecutively in the same test day.
Outcome measures
| Measure |
Control
n=15 Participants
Subjects will receive a solution that resemble the Cannabidiol solution but do not have have its properties
Control (placebo): Subjects will receive a harmless, inactive solution to compare and validate the results of the other arms of the study
|
CBD 400mg
n=14 Participants
Subjects will receive 400mg of cannabidiol
CBD 400 mg: Subjects in Arm CBD 400 mg will receive 400mg of Cannabidiol in each of the three test sessions
|
CBD 800mg
n=13 Participants
Subjects will receive 800 mg of cannabidiol
CBD 800 mg: Subjects in Arm CBD 800 mg will receive 800mg of Cannabidiol in each of the three test sessions
|
|---|---|---|---|
|
Visual Analog Scale for Anxiety (VASA)
First Baseline (before cue video) Session 1
|
1.93 score on a scale
Standard Error 1.751
|
2.86 score on a scale
Standard Error 1.956
|
3.77 score on a scale
Standard Error 2.833
|
|
Visual Analog Scale for Anxiety (VASA)
First Baseline (before cue video) Session 2
|
1.40 score on a scale
Standard Error 1.682
|
1.29 score on a scale
Standard Error 1.541
|
.85 score on a scale
Standard Error 1.463
|
|
Visual Analog Scale for Anxiety (VASA)
First Baseline (before cue video) Session 4
|
.87 score on a scale
Standard Error 1.246
|
1.29 score on a scale
Standard Error 1.490
|
1.25 score on a scale
Standard Error 2.006
|
|
Visual Analog Scale for Anxiety (VASA)
First Post Cue Session 1
|
2.87 score on a scale
Standard Error 2.924
|
3.21 score on a scale
Standard Error 1.626
|
3.54 score on a scale
Standard Error 2.989
|
|
Visual Analog Scale for Anxiety (VASA)
First Post Cue Session 2
|
1.80 score on a scale
Standard Error 1.897
|
2.07 score on a scale
Standard Error 2.303
|
1.31 score on a scale
Standard Error 2.016
|
|
Visual Analog Scale for Anxiety (VASA)
First Post Cue Session 4
|
1.33 score on a scale
Standard Error 1.915
|
1.50 score on a scale
Standard Error 1.345
|
1.67 score on a scale
Standard Error 2.498
|
|
Visual Analog Scale for Anxiety (VASA)
Second Base Line (before cue video) Session 1
|
1.80 score on a scale
Standard Error 2.178
|
1.64 score on a scale
Standard Error 1.906
|
2.77 score on a scale
Standard Error 2.803
|
|
Visual Analog Scale for Anxiety (VASA)
Second Base Line (before cue video) Session 2
|
1.40 score on a scale
Standard Error 1.352
|
1.64 score on a scale
Standard Error 2.205
|
.92 score on a scale
Standard Error 1.382
|
|
Visual Analog Scale for Anxiety (VASA)
Second Base Line (before cue video) Session 4
|
.73 score on a scale
Standard Error 1.223
|
1.86 score on a scale
Standard Error 2.381
|
1.42 score on a scale
Standard Error 2.065
|
|
Visual Analog Scale for Anxiety (VASA)
Second Post Cue Session 1
|
2.13 score on a scale
Standard Error 2.264
|
1.43 score on a scale
Standard Error 1.910
|
1.54 score on a scale
Standard Error 1.664
|
|
Visual Analog Scale for Anxiety (VASA)
Second Post Cue Session 2
|
1.80 score on a scale
Standard Error 2.178
|
2.29 score on a scale
Standard Error 2.463
|
1.15 score on a scale
Standard Error 1.772
|
|
Visual Analog Scale for Anxiety (VASA)
Second Post Cue Session 4
|
1.13 score on a scale
Standard Error 1.302
|
1.14 score on a scale
Standard Error 1.875
|
.75 score on a scale
Standard Error .965
|
|
Visual Analog Scale for Anxiety (VASA)
Post Relaxation video Session 1
|
.40 score on a scale
Standard Error .632
|
1.07 score on a scale
Standard Error 1.269
|
.92 score on a scale
Standard Error 1.188
|
|
Visual Analog Scale for Anxiety (VASA)
Post Relaxation video Session 2
|
.93 score on a scale
Standard Error 1.223
|
1.29 score on a scale
Standard Error 1.590
|
.46 score on a scale
Standard Error .967
|
|
Visual Analog Scale for Anxiety (VASA)
Post Relaxation video Session 4
|
.33 score on a scale
Standard Error 1.047
|
.71 score on a scale
Standard Error .994
|
.50 score on a scale
Standard Error .798
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline for cue sessions 1 and 2, post-cue sessions I and 2 (30 min from baseline) during test days I, II and IV.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. Note, cue sessions occur consecutively in the same test day. Positive affect scores range from 10 - 50. Higher scores represent higher levels of positive affect. Negative affect scores range from 10 - 50. Higher scores represent high levels of negative affect.
Outcome measures
| Measure |
Control
n=15 Participants
Subjects will receive a solution that resemble the Cannabidiol solution but do not have have its properties
Control (placebo): Subjects will receive a harmless, inactive solution to compare and validate the results of the other arms of the study
|
CBD 400mg
n=14 Participants
Subjects will receive 400mg of cannabidiol
CBD 400 mg: Subjects in Arm CBD 400 mg will receive 400mg of Cannabidiol in each of the three test sessions
|
CBD 800mg
n=13 Participants
Subjects will receive 800 mg of cannabidiol
CBD 800 mg: Subjects in Arm CBD 800 mg will receive 800mg of Cannabidiol in each of the three test sessions
|
|---|---|---|---|
|
The Positive and Negative Affect Schedule(PANAS)
Session 1 Neutral Cue Positive PANAS
|
1.48 score on a scale
Standard Deviation 1.07
|
-0.29 score on a scale
Standard Deviation 0.92
|
-0.92 score on a scale
Standard Deviation 1.51
|
|
The Positive and Negative Affect Schedule(PANAS)
Session 1 Drug Cue Positive PANAS
|
-0.45 score on a scale
Standard Deviation 1.23
|
2.7 score on a scale
Standard Deviation 1.32
|
-2.1 score on a scale
Standard Deviation 1.3
|
|
The Positive and Negative Affect Schedule(PANAS)
Session 2 Neutral Cue Positive PANAS
|
-1.93 score on a scale
Standard Deviation 1.79
|
1.64 score on a scale
Standard Deviation 0.99
|
0.26 score on a scale
Standard Deviation 0.82
|
|
The Positive and Negative Affect Schedule(PANAS)
Session 2 Drug Cue Positive PANAS
|
0.71 score on a scale
Standard Deviation 0.64
|
1.08 score on a scale
Standard Deviation 1.4
|
-2.37 score on a scale
Standard Deviation 1.52
|
|
The Positive and Negative Affect Schedule(PANAS)
Session 3 Neutral Cue Positive PANAS
|
0.58 score on a scale
Standard Deviation 0.78
|
2.21 score on a scale
Standard Deviation 0.83
|
2.79 score on a scale
Standard Deviation 1.15
|
|
The Positive and Negative Affect Schedule(PANAS)
Session 3 Drug Cue Positive PANAS
|
1.52 score on a scale
Standard Deviation 0.85
|
0.43 score on a scale
Standard Deviation 1.26
|
4.05 score on a scale
Standard Deviation 1.36
|
|
The Positive and Negative Affect Schedule(PANAS)
Session 1 Neutral Cue Negative PANAS
|
-0.51 score on a scale
Standard Deviation 0.83
|
-0.69 score on a scale
Standard Deviation 0.97
|
-1.48 score on a scale
Standard Deviation 1.22
|
|
The Positive and Negative Affect Schedule(PANAS)
Session 1 Drug Cue Negative PANAS
|
5.31 score on a scale
Standard Deviation 1.85
|
1.26 score on a scale
Standard Deviation 1.93
|
0.7 score on a scale
Standard Deviation 1.33
|
|
The Positive and Negative Affect Schedule(PANAS)
Session 2 Neutral Cue Negative PANAS
|
-3.75 score on a scale
Standard Deviation 0.79
|
-3.01 score on a scale
Standard Deviation 0.88
|
-2.68 score on a scale
Standard Deviation 1.03
|
|
The Positive and Negative Affect Schedule(PANAS)
Session 2 Drug Cue Negative PANAS
|
1.18 score on a scale
Standard Deviation 1.62
|
1.12 score on a scale
Standard Deviation 1.81
|
1.76 score on a scale
Standard Deviation 1.34
|
|
The Positive and Negative Affect Schedule(PANAS)
Session 3 Neutral Cue Negative PANAS
|
-0.06 score on a scale
Standard Deviation 0.52
|
-0.98 score on a scale
Standard Deviation 0.74
|
-0.14 score on a scale
Standard Deviation 0.5
|
|
The Positive and Negative Affect Schedule(PANAS)
Session 3 Drug Cue Negative PANAS
|
1.32 score on a scale
Standard Deviation 0.9
|
0.77 score on a scale
Standard Deviation 0.71
|
0.57 score on a scale
Standard Deviation 0.74
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Test day I: 15 min and 35 min post drug and neutral cueSubjects will be asked to chew on a cotton swab, each time providing us with a saliva sample from which we can detect free cortisol levels and extrapolate serum levels of the stress indicator affected by the video cues. Note, cue sessions occur consecutively in the same test day. Thus, the physiological stress of craving will be monitored and measured across the multiple time points to observe any changes from baseline. Results reported below are mean percent change from baseline following exposure to neutral and heroin-associated cues in Session 1 in subjects with CBD or placebo administration.
Outcome measures
| Measure |
Control
n=15 Participants
Subjects will receive a solution that resemble the Cannabidiol solution but do not have have its properties
Control (placebo): Subjects will receive a harmless, inactive solution to compare and validate the results of the other arms of the study
|
CBD 400mg
n=14 Participants
Subjects will receive 400mg of cannabidiol
CBD 400 mg: Subjects in Arm CBD 400 mg will receive 400mg of Cannabidiol in each of the three test sessions
|
CBD 800mg
n=13 Participants
Subjects will receive 800 mg of cannabidiol
CBD 800 mg: Subjects in Arm CBD 800 mg will receive 800mg of Cannabidiol in each of the three test sessions
|
|---|---|---|---|
|
Physiological Response to Stress - Salivary Cortisol Measures
Neutral Cue 15 min
|
0.69 mean percent change
Standard Error 3.45
|
1.19 mean percent change
Standard Error 6.19
|
-0.87 mean percent change
Standard Error 4.11
|
|
Physiological Response to Stress - Salivary Cortisol Measures
Neutral Cue 35 min
|
-3.84 mean percent change
Standard Error 6.00
|
-9.82 mean percent change
Standard Error 5.93
|
-4.17 mean percent change
Standard Error 7.15
|
|
Physiological Response to Stress - Salivary Cortisol Measures
Drug Cue 15 min
|
11.89 mean percent change
Standard Error 6.70
|
-15.17 mean percent change
Standard Error 7.42
|
-13.84 mean percent change
Standard Error 11.70
|
|
Physiological Response to Stress - Salivary Cortisol Measures
Drug Cue 35 min
|
8.19 mean percent change
Standard Error 10.98
|
-23.74 mean percent change
Standard Error 6.66
|
-20.03 mean percent change
Standard Error 8.54
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Test day I, II, III and IV: at the end of day prior to discharge. Average time point: approximately 150 minutes into the test day.Before being sent home, subjects will be asked to complete the Systematic Assessment for Treatment of Emergent Events (SAFTEE) to ensure that they are not experiencing any negative effects of the treatment. There will also be a debriefing period at the end of each session aimed to minimize any potential increase in craving beyond the clinical laboratory session. At the end of the last study, subjects will be assessed and offered appropriate resources and guidance for seeking help for substance abuse or cravings should they need it after participation in the study has concluded.
Outcome measures
| Measure |
Control
n=15 Participants
Subjects will receive a solution that resemble the Cannabidiol solution but do not have have its properties
Control (placebo): Subjects will receive a harmless, inactive solution to compare and validate the results of the other arms of the study
|
CBD 400mg
n=14 Participants
Subjects will receive 400mg of cannabidiol
CBD 400 mg: Subjects in Arm CBD 400 mg will receive 400mg of Cannabidiol in each of the three test sessions
|
CBD 800mg
n=13 Participants
Subjects will receive 800 mg of cannabidiol
CBD 800 mg: Subjects in Arm CBD 800 mg will receive 800mg of Cannabidiol in each of the three test sessions
|
|---|---|---|---|
|
Adverse Effects - SAFTEE
Chest Pain
|
0 events
|
1 events
|
0 events
|
|
Adverse Effects - SAFTEE
Eye Irritation
|
0 events
|
1 events
|
0 events
|
|
Adverse Effects - SAFTEE
Abdominal Discomfort
|
0 events
|
0 events
|
1 events
|
|
Adverse Effects - SAFTEE
Diarrhea
|
0 events
|
2 events
|
7 events
|
|
Adverse Effects - SAFTEE
Headache
|
2 events
|
1 events
|
0 events
|
|
Adverse Effects - SAFTEE
Joint Pain
|
1 events
|
0 events
|
0 events
|
|
Adverse Effects - SAFTEE
Tired/Fatigue
|
2 events
|
0 events
|
1 events
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 2 times: once at pre-screening and once at test day 4, within 2 weeks of each other.Continuous Performance Test is a computerized assessment of attention. The outcome measures include correct responses (hits), missed responses (misses), incorrect responses (false hits), correct misses, and reaction time of both hits and misses. Mean correct response times (hits) are reported below. Shorter response times indicate better participant outcomes.
Outcome measures
| Measure |
Control
n=15 Participants
Subjects will receive a solution that resemble the Cannabidiol solution but do not have have its properties
Control (placebo): Subjects will receive a harmless, inactive solution to compare and validate the results of the other arms of the study
|
CBD 400mg
n=14 Participants
Subjects will receive 400mg of cannabidiol
CBD 400 mg: Subjects in Arm CBD 400 mg will receive 400mg of Cannabidiol in each of the three test sessions
|
CBD 800mg
n=13 Participants
Subjects will receive 800 mg of cannabidiol
CBD 800 mg: Subjects in Arm CBD 800 mg will receive 800mg of Cannabidiol in each of the three test sessions
|
|---|---|---|---|
|
CBD Effects on Cognitive Behavior
Continuous Performance Task (CPT) - Test Day 4 Correct Responses (hits)
|
49.93 units on a scale (hits)
Standard Deviation 12.1
|
46.2 units on a scale (hits)
Standard Deviation 13.8
|
47.5 units on a scale (hits)
Standard Deviation 14.6
|
|
CBD Effects on Cognitive Behavior
Continuous Performance Task (CPT) - Pre-Screen Correct Responses (hits)
|
40.73 units on a scale (hits)
Standard Deviation 29.6
|
39.13 units on a scale (hits)
Standard Deviation 17.2
|
40.67 units on a scale (hits)
Standard Deviation 17.2
|
Adverse Events
Control
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
CBD 400mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
CBD 800mg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Control
n=15 participants at risk
Subjects will receive a solution that resemble the Cannabidiol solution but do not have have its properties
Control (placebo): Subjects will receive a harmless, inactive solution to compare and validate the results of the other arms of the study
|
CBD 400mg
n=14 participants at risk
Subjects will receive 400mg of cannabidiol
CBD 400 mg: Subjects in Arm CBD 400 mg will receive 400mg of Cannabidiol in each of the three test sessions
|
CBD 800mg
n=13 participants at risk
Subjects will receive 800 mg of cannabidiol
CBD 800 mg: Subjects in Arm CBD 800 mg will receive 800mg of Cannabidiol in each of the three test sessions
|
|---|---|---|---|
|
Nervous system disorders
Headache
|
13.3%
2/15 • Number of events 2 • Adverse events were collected during the course of study participation, approx. 2 weeks.
Adverse events were collected by using SAFTEE (Systematic Assessment for Treatment Emergent Events)
|
7.1%
1/14 • Number of events 1 • Adverse events were collected during the course of study participation, approx. 2 weeks.
Adverse events were collected by using SAFTEE (Systematic Assessment for Treatment Emergent Events)
|
0.00%
0/13 • Adverse events were collected during the course of study participation, approx. 2 weeks.
Adverse events were collected by using SAFTEE (Systematic Assessment for Treatment Emergent Events)
|
|
Musculoskeletal and connective tissue disorders
Joint Pain
|
6.7%
1/15 • Number of events 1 • Adverse events were collected during the course of study participation, approx. 2 weeks.
Adverse events were collected by using SAFTEE (Systematic Assessment for Treatment Emergent Events)
|
0.00%
0/14 • Adverse events were collected during the course of study participation, approx. 2 weeks.
Adverse events were collected by using SAFTEE (Systematic Assessment for Treatment Emergent Events)
|
0.00%
0/13 • Adverse events were collected during the course of study participation, approx. 2 weeks.
Adverse events were collected by using SAFTEE (Systematic Assessment for Treatment Emergent Events)
|
|
Nervous system disorders
Tired/Fatigue
|
13.3%
2/15 • Number of events 2 • Adverse events were collected during the course of study participation, approx. 2 weeks.
Adverse events were collected by using SAFTEE (Systematic Assessment for Treatment Emergent Events)
|
0.00%
0/14 • Adverse events were collected during the course of study participation, approx. 2 weeks.
Adverse events were collected by using SAFTEE (Systematic Assessment for Treatment Emergent Events)
|
7.7%
1/13 • Number of events 1 • Adverse events were collected during the course of study participation, approx. 2 weeks.
Adverse events were collected by using SAFTEE (Systematic Assessment for Treatment Emergent Events)
|
|
Cardiac disorders
Chest Pain
|
0.00%
0/15 • Adverse events were collected during the course of study participation, approx. 2 weeks.
Adverse events were collected by using SAFTEE (Systematic Assessment for Treatment Emergent Events)
|
7.1%
1/14 • Number of events 1 • Adverse events were collected during the course of study participation, approx. 2 weeks.
Adverse events were collected by using SAFTEE (Systematic Assessment for Treatment Emergent Events)
|
0.00%
0/13 • Adverse events were collected during the course of study participation, approx. 2 weeks.
Adverse events were collected by using SAFTEE (Systematic Assessment for Treatment Emergent Events)
|
|
Eye disorders
Eye Irritation
|
0.00%
0/15 • Adverse events were collected during the course of study participation, approx. 2 weeks.
Adverse events were collected by using SAFTEE (Systematic Assessment for Treatment Emergent Events)
|
7.1%
1/14 • Number of events 1 • Adverse events were collected during the course of study participation, approx. 2 weeks.
Adverse events were collected by using SAFTEE (Systematic Assessment for Treatment Emergent Events)
|
0.00%
0/13 • Adverse events were collected during the course of study participation, approx. 2 weeks.
Adverse events were collected by using SAFTEE (Systematic Assessment for Treatment Emergent Events)
|
|
Gastrointestinal disorders
Abdominal Discomfort
|
0.00%
0/15 • Adverse events were collected during the course of study participation, approx. 2 weeks.
Adverse events were collected by using SAFTEE (Systematic Assessment for Treatment Emergent Events)
|
0.00%
0/14 • Adverse events were collected during the course of study participation, approx. 2 weeks.
Adverse events were collected by using SAFTEE (Systematic Assessment for Treatment Emergent Events)
|
7.7%
1/13 • Number of events 1 • Adverse events were collected during the course of study participation, approx. 2 weeks.
Adverse events were collected by using SAFTEE (Systematic Assessment for Treatment Emergent Events)
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/15 • Adverse events were collected during the course of study participation, approx. 2 weeks.
Adverse events were collected by using SAFTEE (Systematic Assessment for Treatment Emergent Events)
|
14.3%
2/14 • Number of events 2 • Adverse events were collected during the course of study participation, approx. 2 weeks.
Adverse events were collected by using SAFTEE (Systematic Assessment for Treatment Emergent Events)
|
30.8%
4/13 • Number of events 7 • Adverse events were collected during the course of study participation, approx. 2 weeks.
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
Phone: 212 824 9314
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place