Substance Abuse Clinical Trial
— CBDOILOfficial title:
Use of CBD Oil for Reducing the Negative Emotional Impact of COVID-19: A Randomized Placebo-Controlled Clinical Trial
Verified date | November 2023 |
Source | University of Texas at Austin |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Our purpose is to conduct a 4-arm placebo-controlled clinical trial to investigate the relative clinical efficacy of 300 mg. of pure hemp-derived CBD isolate, 300 mg. of full spectrum CBD oil, 300 mg. of broad- spectrum CBD Oil, or Placebo oil among adults presenting with COVID-19 -induced stress reactions including one or more of the following: anxiety, depression, anger, substance use, or sleep disturbance.
Status | Suspended |
Enrollment | 200 |
Est. completion date | December 31, 2023 |
Est. primary completion date | December 31, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | INCLUSION CRITERIA: - Displays elevated symptom scores on one or more of the following established assessment instruments for depression (PROMIS-Depression), anxiety (PROMIS-Anxiety), Anger (PROMIS-Anger), sleep disturbance (PROMIS-Sleep); or Alcohol/Substance (PROMIS-Alcohol; PROMIS- Substance Use) - Age between 18 to 70; - Fluent in English; - Has home access to the Internet; - Willingness to provide signed informed consent; - Willingness to refrain from all non-study CBD products during the 6-week study period; - Willing to complete a brief pre-study 7-day online symptom monitoring log; - Currently residing in the United States EXCLUSION CRITERIA: - History of a suicide attempt within the past 6 months - Any medical problem that would preclude participating in the study including liver disease - Current use of warfarin or other prescribed blood thinners, - Currently taking seizure medications such as valproate, lamotrigine, or clobazam; - Currently taking thyroid medications such as levothyroxine; - Currently taking heart rhythm medications such as amiodarone; - Currently taking anti-hypertension medications; - Pregnant or planning to become pregnant within the next 6 weeks. - History of adverse reaction to CBD oil or other CBD products. - Allergic to coconut oil. |
Country | Name | City | State |
---|---|---|---|
United States | University of Texas at Austin, Laboratory for the Study of Anxiety Disorders | Austin | Texas |
Lead Sponsor | Collaborator |
---|---|
University of Texas at Austin | SunFlora.Inc, Way West Wellness |
United States,
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* Note: There are 14 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | PROMIS Emotional Distress Index | This measure is a 43-item patient-rated emotional distress symptom scale consisting of 6 sub-factors (Depression, Anxiety, Anger, Alcohol Use, Substance Use, and Sleep Disturbance). Each symptom is rated over a 7-day period on a 5-point scale. | Week 0-Baseline | |
Primary | PROMIS Emotional Distress Index | This measure is a 43-item patient-rated emotional distress symptom scale consisting of 6 sub-factors (Depression, Anxiety, Anger, Alcohol Use, Substance Use, and Sleep Disturbance). Each symptom is rated over a 7-day period on a 5-point scale. | Week 1-Treatment | |
Primary | PROMIS Emotional Distress Index | This measure is a 43-item patient-rated emotional distress symptom scale consisting of 6 sub-factors (Depression, Anxiety, Anger, Alcohol Use, Substance Use, and Sleep Disturbance). Each symptom is rated over a 7-day period on a 5-point scale. | Week 2-Treatment | |
Primary | PROMIS Emotional Distress Index | This measure is a 43-item patient-rated emotional distress symptom scale consisting of 6 sub-factors (Depression, Anxiety, Anger, Alcohol Use, Substance Use, and Sleep Disturbance). Each symptom is rated over a 7-day period on a 5-point scale. | Week 3-Treatment | |
Primary | PROMIS Emotional Distress Index | This measure is a 43-item patient-rated emotional distress symptom scale consisting of 6 sub-factors (Depression, Anxiety, Anger, Alcohol Use, Substance Use, and Sleep Disturbance). Each symptom is rated over a 7-day period on a 5-point scale. | Week 4-Treatment | |
Primary | PROMIS Emotional Distress Index | This measure is a 43-item patient-rated emotional distress symptom scale consisting of 6 sub-factors (Depression, Anxiety, Anger, Alcohol Use, Substance Use, and Sleep Disturbance). Each symptom is rated over a 7-day period on a 5-point scale. | Week 5-Follow-up | |
Secondary | PROMIS Depression Scale | This measure is an 8-item patient-rated depression symptom scale. Each symptom is rated over a 7-day period on a 5-point scale ranging from 1 (Never) to 5 (Always). | Week 0-Baseline | |
Secondary | PROMIS Depression Scale | This measure is an 8-item patient-rated depression symptom scale. Each symptom is rated over a 7-day period on a 5-point scale ranging from 1 (Never) to 5 (Always). | Week 1-Treatment | |
Secondary | PROMIS Depression Scale | This measure is an 8-item patient-rated depression symptom scale. Each symptom is rated over a 7-day period on a 5-point scale ranging from 1 (Never) to 5 (Always). | Week 2-Treatment | |
Secondary | PROMIS Depression Scale | This measure is an 8-item patient-rated depression symptom scale. Each symptom is rated over a 7-day period on a 5-point scale ranging from 1 (Never) to 5 (Always). | Week 3-Treatment | |
Secondary | PROMIS Depression Scale | This measure is an 8-item patient-rated depression symptom scale. Each symptom is rated over a 7-day period on a 5-point scale ranging from 1 (Never) to 5 (Always). | Week 4-Treatment | |
Secondary | PROMIS Depression Scale | This measure is an 8-item patient-rated depression symptom scale. Each symptom is rated over a 7-day period on a 5-point scale ranging from 1 (Never) to 5 (Always). | Week 5-Follow-up | |
Secondary | PROMIS Anxiety Scale | This measure is an 8-item patient-rated anxiety symptom scale. Each symptom is rated over a 7-day period on a 5-point scale ranging from 1 (Never) to 5 (Always). | Week 0- Baseline | |
Secondary | PROMIS Anxiety Scale | This measure is an 8-item patient-rated anxiety symptom scale. Each symptom is rated over a 7-day period on a 5-point scale ranging from 1 (Never) to 5 (Always). | Week 1-Treatment | |
Secondary | PROMIS Anxiety Scale | This measure is an 8-item patient-rated anxiety symptom scale. Each symptom is rated over a 7-day period on a 5-point scale ranging from 1 (Never) to 5 (Always). | Week 2-Treatment | |
Secondary | PROMIS Anxiety Scale | This measure is a 7-item patient-rated anxiety symptom scale. Each symptom is rated over a 7-day period on a 5-point scale ranging from 1 (Never) to 5 (Always). | Week 3-Treatment | |
Secondary | PROMIS Anxiety Scale | This measure is a 7-item patient-rated anxiety symptom scale. Each symptom is rated over a 7-day period on a 5-point scale ranging from 1 (Never) to 5 (Always). | Week 4-Treatment | |
Secondary | PROMIS Anxiety Scale | This measure is a 7-item patient-rated anxiety symptom scale. Each symptom is rated over a 7-day period on a 5-point scale ranging from 1 (Never) to 5 (Always). | Week 5-Follow-up | |
Secondary | PROMIS Anger Scale | This measure is a 5-item patient-rated anger symptom scale. Each symptom is rated over a 7-day period on a 5-point scale ranging from 1 (Never) to 5 (Always). | Week 0- Baseline | |
Secondary | PROMIS Anger Scale | This measure is a 5-item patient-rated anger symptom scale. Each symptom is rated over a 7-day period on a 5-point scale ranging from 1 (Never) to 5 (Always). | Week 1- Treatment | |
Secondary | PROMIS Anger Scale | This measure is a 5-item patient-rated anger symptom scale. Each symptom is rated over a 7-day period on a 5-point scale ranging from 1 (Never) to 5 (Always). | Week 2- Treatment | |
Secondary | PROMIS Anger Scale | This measure is a 5-item patient-rated anger symptom scale. Each symptom is rated over a 7-day period on a 5-point scale ranging from 1 (Never) to 5 (Always). | Week 3- Treatment | |
Secondary | PROMIS Anger Scale | This measure is a 5-item patient-rated anger symptom scale. Each symptom is rated over a 7-day period on a 5-point scale ranging from 1 (Never) to 5 (Always). | Week 4- Treatment | |
Secondary | PROMIS Anger Scale | This measure is a 5-item patient-rated anger symptom scale. Each symptom is rated over a 7-day period on a 5-point scale ranging from 1 (Never) to 5 (Always). | Week 5- Follow-up | |
Secondary | PROMIS Alcohol Negative Consequences Scale | This measure is a 7-item patient-rated index of alcohol-related problems. Each item is rated over a 7-day period on a 5-point scale ranging from 1 (Never) to 5 (Always). | Week 0- Baseline | |
Secondary | PROMIS Alcohol Negative Consequences Scale | This measure is a 7-item patient-rated index of alcohol-related problems. Each item is rated over a 7-day period on a 5-point scale ranging from 1 (Never) to 5 (Always). | Week 1- Treatment | |
Secondary | PROMIS Alcohol Negative Consequences Scale | This measure is a 7-item patient-rated index of alcohol-related problems. Each item is rated over a 7-day period on a 5-point scale ranging from 1 (Never) to 5 (Always). | Week 2- Treatment | |
Secondary | PROMIS Alcohol Negative Consequences Scale | This measure is a 7-item patient-rated index of alcohol-related problems. Each item is rated over a 7-day period on a 5-point scale ranging from 1 (Never) to 5 (Always). | Week 3- Treatment | |
Secondary | PROMIS Alcohol Negative Consequences Scale | This measure is a 7-item patient-rated index of alcohol-related problems. Each item is rated over a 7-day period on a 5-point scale ranging from 1 (Never) to 5 (Always). | Week 4- Treatment | |
Secondary | PROMIS Alcohol Negative Consequences Scale | This measure is a 7-item patient-rated index of alcohol-related problems. Each item is rated over a 7-day period on a 5-point scale ranging from 1 (Never) to 5 (Always). | Week 5- Follow-up | |
Secondary | PROMIS Sleep Disturbance Scale | This measure is an 8-item patient-rated index of sleep disturbance. Each item is rated over a 7-day period on a 5-point scale ranging from 1 (Not at all) to 5 (Very Much). | Week 0- Baseline | |
Secondary | PROMIS Sleep Disturbance Scale | This measure is an 8-item patient-rated index of sleep disturbance. Each item is rated over a 7-day period on a 5-point scale ranging from 1 (Not at all) to 5 (Very Much). | Week 1- Treatment | |
Secondary | PROMIS Sleep Disturbance Scale | This measure is an 8-item patient-rated index of sleep disturbance. Each item is rated over a 7-day period on a 5-point scale ranging from 1 (Not at all) to 5 (Very Much). | Week 2- Treatment | |
Secondary | PROMIS Sleep Disturbance Scale | This measure is an 8-item patient-rated index of sleep disturbance. Each item is rated over a 7-day period on a 5-point scale ranging from 1 (Not at all) to 5 (Very Much). | Week 3- Treatment | |
Secondary | PROMIS Sleep Disturbance Scale | This measure is an 8-item patient-rated index of sleep disturbance. Each item is rated over a 7-day period on a 5-point scale ranging from 1 (Not at all) to 5 (Very Much). | Week 4- Treatment | |
Secondary | PROMIS Sleep Disturbance Scale | This measure is an 8-item patient-rated index of sleep disturbance. Each item is rated over a 7-day period on a 5-point scale ranging from 1 (Not at all) to 5 (Very Much). | Week 5- Follow-up | |
Secondary | COVID-19 Coping Self-Efficacy | This measure is a 15-item author-constructed patient-rated index of COVID-19 Coping Self-Efficacy | Week 0- Baseline | |
Secondary | COVID-19 Coping Self-Efficacy | This measure is a 15-item author-constructed patient-rated index of COVID-19 Coping Self-Efficacy | Week 1- Treatment | |
Secondary | COVID-19 Coping Self-Efficacy | This measure is a 15-item author-constructed patient-rated index of COVID-19 Coping Self-Efficacy | Week 2- Treatment | |
Secondary | COVID-19 Coping Self-Efficacy | This measure is a 15-item author-constructed patient-rated index of COVID-19 Coping Self-Efficacy | Week 3- Treatment | |
Secondary | COVID-19 Coping Self-Efficacy | This measure is a 15-item author-constructed patient-rated index of COVID-19 Coping Self-Efficacy | Week 4- Treatment | |
Secondary | COVID-19 Coping Self-Efficacy | This measure is a 15-item author-constructed patient-rated index of COVID-19 Coping Self-Efficacy | Week 5- Follow-up | |
Secondary | Sheehan Disability Scale | This measure is a 3-item patient-rated index of level of functional impairment. | Week 0- Baseline | |
Secondary | Sheehan Disability Scale | This measure is a 3-item patient-rated index of level of functional impairment. | Week 5- Follow-up |
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