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| ID | Type | Description | Link |
|---|---|---|---|
| UL1TR002645 | U.S. NIH Grant/Contract | View source | |
| KL2TR002646 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Advancing Translational Sciences (NCATS) | NIH |
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The primary goal of this pilot project is to demonstrate the safety and feasibility of using Cannabidiol (CBD) in combination with standard of care prolonged exposure (PE) psychotherapy to reduce PTSD symptoms.
This study is an early Phase II double-blind, pilot randomized controlled clinical trial. The study team will use a permuted block randomization design stratified by a Posttraumatic Stress Disorder (PTSD) severity median score on the PTSD Checklist (PCL-5) derived from a recently completed STRONG STAR repository. Participants will be up to 24 individuals with PTSD to investigate the safety, feasibility, and PTSD symptom change associated with CBD 250mg taken twice a day for 18 days (n=up to 12) vs. placebo (n=up to12) in combination with a standard of care, 10-sessions massed PE psychotherapy administered over 2 weeks. Aims 2 and 3 will evaluate biochemical and physiological outcomes associated with the brain endocannabinoid (eCB) and PTSD that may be affected by CBD. Permuted block randomization is advantageous in small clinical trials to ensure equal allocation of participants in each condition. Participant randomization will be subdivided into randomized blocks of four, two patients in each block will be assigned to CBD and two will be assigned to placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cannabidiol (CBD) | Active Comparator | Epidiolex oral solution 500mg (5ml) per day |
|
| Placebo | Placebo Comparator | Placebo oral solution 5ml per day |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cannabidiol (CBD) oral solution | Drug | An oral strawberry flavored liquid, taken as a 2.5ml (250mg) dose twice a day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinician Administered PTSD Scale (CAPS-5) | The CAPS-5 is structured interview that assesses the Diagnostic and Statistical Manual of Mental Disorders v5 (DSM-5) criteria for PTSD. Each item is rated on a severity scale ranging from 0 (Absent) to 4 (Extreme/incapacitating) and combines information about frequency and intensity for each of the 20 symptoms.Subscale scores are calculated by summing severity scores for items in the following PTSD symptom clusters: re-experiencing, avoidance, negative alterations in cognitions and mood, and hyperarousal. Scores ≥ 25 indicate a probable diagnosis of PTSD. Scores range from 0 to 80. Change in score will be reported. | Baseline and at about 45 days (1 month follow-up visit) |
| Posttraumatic Stress Disorder Checklist (PCL-5) | The PCL-5 is a 20-item self-report measure update of the PCL designed to assess PTSD symptoms as defined by the DSM-5. The PCL-5 evaluates how much participants have been bothered by PTSD symptoms in the past week (for all assessments during treatment) or the past two weeks (all other assessment time points) as a result of a specific life event. Each item of the PCL-5 is scored on a five-point scale ranging from 0 "not at all") to 4 ("extremely). Scores range from 0 to 80 with a higher score indicating that subjects have been bothered more by PTSD symptoms. Change in score will be reported. | Baseline and at about 45 days (1 month follow-up visit) |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Health Questionnaire-9 (PHQ-9) | It consists of 9 items that assess both affective and somatic symptoms related to depression and depressive disorders; these 9 items correspond to the diagnostic criteria for Diagnostic Statistical Manual of Mental Disorders - Major Depressive Disorder (DSM MDD). Respondents rate the frequency with which they have been bothered by depressive symptoms within the past two weeks on a scale ranging from 0 ("not at all") to 3 ("nearly every day"). Scores on all items are summed to obtain a total severity score between 0 and 27. Scores reflect no significant depressive symptoms (0-4), mild depressive symptoms (5-9), moderate depressive symptoms (10-14), moderately severe depressive symptoms (15-19), and severe depressive symptoms (>19). Change in score is reported. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Casey Straud, PsyD | The University of Texas Health Science Center at San Antonio | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas Health Science Center at San Antonio - STRONG STAR Northwest Center | San Antonio | Texas | 78229 | United States |
A STRONG STAR Institutional Review board (IRB) approved Repository to enable the STRONG STAR Consortium to store specimens and data for future use. Study databases are established and maintained by the STRONG STAR Data and Statistics Services. All Repository data will be identified with a different code number that can be cross linked to the original study code only through records maintained by the STRONG STAR Data and Statistics Services. At the conclusion of this study, participants who signed the consent to have their data placed in the STRONG STAR Repository will be maintained under the UT Health San Antonio IRB-approved Repository protocol. For participants who decline participation in the STRONG STAR Repository, their data will be de-identified, and the data maintained in the Repository without identifiers.
Summary results will also be shared on ClincalTrials.gov.
After study enrollment is closed and data analysis is complete. Data will be stored in the repository and accessible as long as the IRB approval for this data base remains current.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cannabidiol (CBD) | Epidiolex oral solution 500mg (5ml) per day Cannabidiol (CBD) oral solution: An oral strawberry flavored liquid, taken as a 2.5ml (250mg) dose twice a day Massed Prolonged Exposure (mPE): mPE, delivered daily Monday through Friday over two weeks, utilizes exposure-based interventions to target psychological mechanisms (i.e., experiential and behavioral avoidance; maladaptive cognitive changes) that are thought to maintain trauma-related symptoms. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 15, 2022 |
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A double-blind randomized controlled clinical trial. Permuted block randomization will ensure equal allocation of participants to either study drug or placebo. Randomization will be performed by a designated study team member.
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A compounding pharmacy will supply both the study drug and a matching strawberry flavored liquid.
| Placebo | Drug | An inert strawberry flavored oral solution, taken as a 2.5ml dose twice a day |
|
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| Massed Prolonged Exposure (mPE) | Behavioral | mPE, delivered daily Monday through Friday over two weeks, utilizes exposure-based interventions to target psychological mechanisms (i.e., experiential and behavioral avoidance; maladaptive cognitive changes) that are thought to maintain trauma-related symptoms. |
|
|
| Baseline and at about 45 Days (1 month follow-up visit) |
| FG001 | Placebo | Placebo oral solution 5ml per day Placebo: An inert strawberry flavored oral solution, taken as a 2.5ml dose twice a day Massed Prolonged Exposure (mPE): mPE, delivered daily Monday through Friday over two weeks, utilizes exposure-based interventions to target psychological mechanisms (i.e., experiential and behavioral avoidance; maladaptive cognitive changes) that are thought to maintain trauma-related symptoms. |
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| NOT COMPLETED |
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21 were randomized into CBD (n=11) or placebo (n=10).
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| ID | Title | Description |
|---|---|---|
| BG000 | Cannabidiol (CBD) | Epidiolex oral solution 500mg (5ml) per day Cannabidiol (CBD) oral solution: An oral strawberry flavored liquid, taken as a 2.5ml (250mg) dose twice a day Massed Prolonged Exposure (mPE): mPE, delivered daily Monday through Friday over two weeks, utilizes exposure-based interventions to target psychological mechanisms (i.e., experiential and behavioral avoidance; maladaptive cognitive changes) that are thought to maintain trauma-related symptoms. |
| BG001 | Placebo | Placebo oral solution 5ml per day Placebo: An inert strawberry flavored oral solution, taken as a 2.5ml dose twice a day Massed Prolonged Exposure (mPE): mPE, delivered daily Monday through Friday over two weeks, utilizes exposure-based interventions to target psychological mechanisms (i.e., experiential and behavioral avoidance; maladaptive cognitive changes) that are thought to maintain trauma-related symptoms. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 21 were randomized into CBD (n=11) or placebo (n=10). 1 individual in the placebo condition was not included in analyses (A PI drop due to participant non-compliance and loss of eligibility. Data gathered from this participant was not evaluable). | Mean | Standard Deviation | years |
| ||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Clinician Administered PTSD Scale (CAPS-5) | The CAPS-5 is structured interview that assesses the Diagnostic and Statistical Manual of Mental Disorders v5 (DSM-5) criteria for PTSD. Each item is rated on a severity scale ranging from 0 (Absent) to 4 (Extreme/incapacitating) and combines information about frequency and intensity for each of the 20 symptoms.Subscale scores are calculated by summing severity scores for items in the following PTSD symptom clusters: re-experiencing, avoidance, negative alterations in cognitions and mood, and hyperarousal. Scores ≥ 25 indicate a probable diagnosis of PTSD. Scores range from 0 to 80. Change in score will be reported. | Intent to treat analysis were completed in the total sample (n=21; CBD = 11, Placebo = 10). | Posted | Mean | Standard Error | score on a scale | Baseline and at about 45 days (1 month follow-up visit) |
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| Primary | Posttraumatic Stress Disorder Checklist (PCL-5) | The PCL-5 is a 20-item self-report measure update of the PCL designed to assess PTSD symptoms as defined by the DSM-5. The PCL-5 evaluates how much participants have been bothered by PTSD symptoms in the past week (for all assessments during treatment) or the past two weeks (all other assessment time points) as a result of a specific life event. Each item of the PCL-5 is scored on a five-point scale ranging from 0 "not at all") to 4 ("extremely). Scores range from 0 to 80 with a higher score indicating that subjects have been bothered more by PTSD symptoms. Change in score will be reported. | Intent to treat analysis were completed in the total sample (n=21; CBD = 11, Placebo = 10). | Posted | Mean | Standard Error | score on a scale | Baseline and at about 45 days (1 month follow-up visit) |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Patient Health Questionnaire-9 (PHQ-9) | It consists of 9 items that assess both affective and somatic symptoms related to depression and depressive disorders; these 9 items correspond to the diagnostic criteria for Diagnostic Statistical Manual of Mental Disorders - Major Depressive Disorder (DSM MDD). Respondents rate the frequency with which they have been bothered by depressive symptoms within the past two weeks on a scale ranging from 0 ("not at all") to 3 ("nearly every day"). Scores on all items are summed to obtain a total severity score between 0 and 27. Scores reflect no significant depressive symptoms (0-4), mild depressive symptoms (5-9), moderate depressive symptoms (10-14), moderately severe depressive symptoms (15-19), and severe depressive symptoms (>19). Change in score is reported. | Intent to treat analysis were completed in the total sample (n=21; CBD = 11, Placebo = 10). | Posted | Mean | Standard Error | score on a scale | Baseline and at about 45 Days (1 month follow-up visit) |
|
Enrolled participants were monitored for AEs at Interim Assessment 1 (PE Session 1), Interim Assessment 2 (PE Session 5), Interim Assessment 3 (PE Session 10), and at the 1-month follow-up.
AEs were assessed/monitored using standardized procedures. At each assessment period, participants were asked "Have you experienced any changes for the worse since your last visit?" Reported events were documented by the research team member. Participants were asked about the temporal nature (start/stop date), severity, impact on functioning, and whether the event is study-related. AEs were reviewed during biweekly study meetings to ensure reliable coding and participant safety.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cannabidiol (CBD) | Epidiolex oral solution 500mg (5ml) per day Cannabidiol (CBD) oral solution: An oral strawberry flavored liquid, taken as a 2.5ml (250mg) dose twice a day Massed Prolonged Exposure (mPE): mPE, delivered daily Monday through Friday over two weeks, utilizes exposure-based interventions to target psychological mechanisms (i.e., experiential and behavioral avoidance; maladaptive cognitive changes) that are thought to maintain trauma-related symptoms. | 0 | 11 | 0 | 11 | 10 | 11 |
| EG001 | Placebo | Placebo oral solution 5ml per day Placebo: An inert strawberry flavored oral solution, taken as a 2.5ml dose twice a day Massed Prolonged Exposure (mPE): mPE, delivered daily Monday through Friday over two weeks, utilizes exposure-based interventions to target psychological mechanisms (i.e., experiential and behavioral avoidance; maladaptive cognitive changes) that are thought to maintain trauma-related symptoms. | 0 | 10 | 0 | 10 | 7 | 10 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastrointestinal Issues | Gastrointestinal disorders | Systematic Assessment | diarrhea, cramps, nausea |
| |
| Emotional Problems | Psychiatric disorders | Systematic Assessment | increased emotional distress, anger, emotional numbness |
| |
| Fatigue | Psychiatric disorders | Systematic Assessment | fatigue attributed to prolonged exposure |
| |
| Sleep Disturbance | Psychiatric disorders | Systematic Assessment | increased nightmares and increased difficulty falling/staying asleep |
| |
| Sensation from study drug | General disorders | Systematic Assessment | instant burning/warm sensation when taking study drug |
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| Appetite Increase | General disorders | Systematic Assessment |
| ||
| Drowsiness | Nervous system disorders | Systematic Assessment | drowsiness attributed to study drug |
| |
| Joint Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment | Increased joint pain in knee attributed to stopping medication following participation |
| |
| Physiological Arousal | Psychiatric disorders | Systematic Assessment | Increased physiological arousal attributed to prolonged exposure. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Casey Straud | University of Texas Health Science Center at San Antonio | 210-562-6742 | straud@uthscsa.edu |
| May 9, 2024 |
| Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 25, 2022 | Aug 22, 2023 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D002185 | Cannabidiol |
| D001521 | Behavior Therapy |
| ID | Term |
|---|---|
| D002186 | Cannabinoids |
| D013729 | Terpenes |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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| Male |
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| White, Hispanic |
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| White, Non-Hispanic |
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Placebo oral solution 5ml per day Placebo: An inert strawberry flavored oral solution, taken as a 2.5ml dose twice a day Massed Prolonged Exposure (mPE): mPE, delivered daily Monday through Friday over two weeks, utilizes exposure-based interventions to target psychological mechanisms (i.e., experiential and behavioral avoidance; maladaptive cognitive changes) that are thought to maintain trauma-related symptoms. |
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