Acute and Short-term Effects of Cannabidiol Admin on Cue-induced Craving in Drug-abstinent Heroin Dependent Humans
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ClinicalTrials.gov Identifier: NCT01605539 |
Recruitment Status :
Completed
First Posted : May 25, 2012
Results First Posted : November 28, 2016
Last Update Posted : August 11, 2020
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Study Type | Interventional |
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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 |
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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 | |
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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 | |
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[Not Specified]
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 3 participants | 6 participants | 9 participants | |
<=18 years |
0 0.0%
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0 0.0%
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0 0.0%
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Between 18 and 65 years |
3 100.0%
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6 100.0%
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9 100.0%
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>=65 years |
0 0.0%
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0 0.0%
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0 0.0%
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 3 participants | 6 participants | 9 participants | |
Female |
0 0.0%
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0 0.0%
|
0 0.0%
|
|
Male |
3 100.0%
|
6 100.0%
|
9 100.0%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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United States | Number Analyzed | 3 participants | 6 participants | 9 participants |
3 | 6 | 9 |
Name/Title: | Yasmin Hurd, PhD |
Organization: | Icahn School of Medicine at Mount Sinai |
Phone: | 212-824-9314 |
EMail: | yasmin.hurd@mssm.edu |
Responsible Party: | Yasmin Hurd, Hurd,Yasmin, Ph.D. |
ClinicalTrials.gov Identifier: | NCT01605539 |
Other Study ID Numbers: |
R21 DA027781(2) |
First Submitted: | May 2, 2012 |
First Posted: | May 25, 2012 |
Results First Submitted: | September 28, 2015 |
Results First Posted: | November 28, 2016 |
Last Update Posted: | August 11, 2020 |