Acute and Short-term Effects of CBD on Cue-induced Craving in Drug-abstinent Heroin-dependent Humans
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|ClinicalTrials.gov Identifier: NCT02539823|
Recruitment Status : Completed
First Posted : September 3, 2015
Last Update Posted : February 21, 2018
|Condition or disease||Intervention/treatment||Phase|
|Opiate Addiction||Drug: CBD 400 mg Drug: CBD 800 mg Drug: Control (placebo)||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||45 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|Official Title:||To Characterize the Acute and Short-term Effects of Cannabidiol (CBD) Administration on Cue-induced Craving in Drug-abstinent Heroin-dependent Humans|
|Study Start Date :||September 2015|
|Primary Completion Date :||May 24, 2017|
|Study Completion Date :||May 24, 2017|
Placebo Comparator: Control
Subjects will receive a solution that resemble the Cannabidiol solution but do not have have its properties
Drug: Control (placebo)
Subjects will receive a harmless, inactive solution to compare and validate the results of the other arms of the study
Other Name: CBD
Experimental: CBD 400mg
Subjects will receive 400mg of cannabidiol
Drug: CBD 400 mg
Subjects in Arm CBD 400 mg will receive 400mg of Cannabidiol in each of the three test sessions
Other Name: CBD
Experimental: CBD 800mg
Subjects will receive 800 mg of cannabidiol
Drug: CBD 800 mg
Subjects in Arm CBD 800 mg will receive 800mg of Cannabidiol in each of the three test sessions
Other Name: CBD
- Changes in Cue-Induced In-Clinic Craving (from baseline to post-cue (30 minutes), and from test visit 1 through test visit 4 (1 week)) - via the Visual Analog Scale for Craving (VASC) [ Time Frame: VASC: test visits 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 visit 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. In this way, changes in craving from baseline (pre-cue to post-cue within each test visit), as well as changes in cue-induced craving over the short-term (test visit 1 through test visit 4 a week later) will be monitored and measured.
- Changes in Out-of-Clinic Craving (from pre-dose to approximately 4-6 hours post-dose; and from test visit 1 to test visit 4 or 1 week) - via the Heroin Craving Questionnaire (HCQ) [ Time Frame: HCQ: once in clinic pre-dose at each test visit, and once at home after each test visit. ]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 (1 week later).
- Vital Signs [ Time Frame: At drug/placebo admin, baseline for cue 1, 10 min post-cue I, 30 min post cue I, baseline for cue 2, 10 min post cue II, 30 min post cue II or prior to discharge approximately 2.5 hours from session start on average (no cue sessions in test visit III) ]Blood 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.
- CBD Effects on Cognitive Behavior [ Time Frame: 2 times: once at pre-screening (visit 1) and once at test session 4 (visit 5), within 2 weeks of each other. ]Subjects will be asked to complete a battery of performance tests conducted to examine subtle changes in mental acuity, learning and memory, and other aspects of performance that will provide insight about cannabidiol's effects on cognitive behavior. The battery will comprise the Continuous Performance, Digit Span Backwards, and Digit-Symbol Substitution tasks.
- Visual Analog Scale for Anxiety (VASA) [ Time Frame: Test visit 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 session start on average); Test visit 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).
- The Positive and Negative Affect Schedule(PANAS) [ Time Frame: Baseline for cue sessions 1 and 2, post-cue sessions I and 2 (30 min from baseline) during test visits 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.
- Physiological Response to Stress - Salivary Cortisol Measures [ Time Frame: Test visit I, II and IV: at drug/placebo admin, baseline for cue session 1, 10 min post-cue I, 30 min post cue I, baseline for cue 2, 10 min post cue II, 30 min post cue II ]Subjects 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. Thus, the physiological stress of craving will be monitored and measured across the multiple time points to observe any changes from baseline.
- Adverse Effects - SAFTEE [ Time Frame: Test visit I, II, III and IV: at the end of visit prior to discharge. Average time point: approximately 150 minutes into the session. ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02539823
|United States, New York|
|Mount Sinai Beth Israel|
|New York, New York, United States, 10003|
|Principal Investigator:||Yasmin Hurd, PhD||Mount Sinai Health System|