Trial · NCT06222268
Registered outcomes21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 21
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Treatment Response | Through study completion, an average of 12 months | Clinician Administered PTSD Scale for DSM-5 (CAPS-5 Score), anxiety, mood, suicidality, disability. The CAPS-5 is a clinician interview that determines the presence and severity of PTSD consistent with the Diagnostic \& Statistical Manual 5 (DSM-5) and allows for assessing changes in symptom severity over time. PTSD diagnosis is based on meeting the DSM-5 symptom cluster criteria (minimum threshold of symptoms with a score ≥ 2) with a qualifying criterion A index trauma. The CAPS-5 Total Severity Score is calculated by summing the total score for each of the four symptom categories to assess past-month PTSD symptoms on a specific traumatic event: intrusion (Category B), Avoidance (Category C), Mood and Cognition (Category D), and Hyperarousal (Category E). CAPS-5 Total Severity scores range from 0-80, where higher scores indicate worse PTSD severity. |
| Secondary | Brain measures | Pre and post treatment-Through study completion, an average of 12 months | Functional magnetic resonance imaging (fMRI) will be used to measure blood oxygen level dependent (BOLD) changes in regions of interest (amygdala, ventromedial prefrontal cortex, hippocampus) during tasks. |
| Secondary | Skin conductance response | through study completion, an average of 12 months | Skin conductance is a measure of physiological arousal, it can be used to measure periods of heightened emotional responses to stimuli, here it is used to confirm fear conditioning. |
| Secondary | Drug Effects Questionnaire (DEQ) | through study completion, an average of 12 months | Subjective ratings of drug effects on from 1-5 on the following scale: "feel", "high", and "like" |
| Secondary | Visual Analogue Scale of Mood (VAS) | through study completion, an average of 12 months | Subjective ratings of mood and drug effects on a 0-100 scale. Higher numbers on the scale reflect stronger experiences of different mood and drug effects. Each item is scored individually. There is no overall score. |
| Secondary | Quality of Life Inventory (QOLI) | through study completion, an average of 12 months | assessment of well-being and satisfaction of life. The questionnaire is a 32-item scale ranging from -6 (extreme dissatisfaction) to +6 (extreme satisfaction). Scores range from 1-77 with higher scores indicating higher life satisfaction. |
| Secondary | Pittsburgh Sleep Quality Index (PSQI) | through study completion, an average of 12 months | Used to evaluate overall sleep quality. Participants rate sleep quality on a 4 point scale from 0 - "not during the last month" to 3 - "three or more times per week" relating to various sleep concerns. Scores range from 1-21 with higher scores indicating worse sleep quality. |
| Secondary | Epworth Sleepiness Scale (ESS) | through study completion, an average of 12 months | assessment of daytime sleepiness in adults. Participants rate feeling sleepy during various activities on a 4 point scale from 0 - "no chance of dozing" to 3 - "high chance of dozing". Scores range from 0-24 and are characterised as follows: 0-7:It is unlikely that you are abnormally sleepy. 8-9:You have an average amount of daytime sleepiness. 10-15:You may be excessively sleepy depending on the situation. You may want to consider seeking medical attention. 16-24:You are excessively sleepy and should consider seeking medical attention. |
| Secondary | Brief Pain Inventory (BPI) | through study completion, an average of 12 months | assessment of the severity of pain and its impact on functioning. The scale consists of nine questions with a mixture of visual analogue scales and written answers. Questions 3-6 measure current pain levels on a scale from 1 - "no pain" to 10 "pain as bad as you can imagine" with higher ratings suggesting greater levels of pain (range 0-40). Question 9 has 7 nested questions (rated from 0 - 'Does not interfere" to 10 - "Completely interferes") relating to how much pain is interfering with mood, everyday tasks and sociability (range 0-70), a higher rating indicates greater issues arising from pain. |
| Secondary | Short form 36 | through study completion, an average of 12 months | assessment of general health questions. Each question is scored on a range from 0-100 with higher scores indicating a more favourable health state. |
| Secondary | fMRI | through study completion, an average of 12 months | using fMRI we can look at the differences between individuals during fear processing responses. |
| Secondary | Psychophysiology | through study completion, an average of 12 months | Skin conductance response (SCR): change in SCR \[peak amplitude from 0.5-4.5 sec following stimulus presentation minus average 2 second baseline prior to stimulus presentation\]. |
| Secondary | DNA analysis | through study completion, an average of 12 months | Plasma samples collected are analyzed for genetic and epigenetic markers of endocannabinoid system functioning. |
| Secondary | Cannabinoid concentration - Blood | through study completion, an average of 12 months | As well as measuring drug levels during treatment, blood samples allow us to track the activity of the endocannabinoid system throughout the treatment. A novel approach to determine whether Delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD) function differently in the endocannabinoid system. |
| Secondary | Urine Drug Toxicology tests | through study completion, an average of 12 months | Urine samples are also provided on regular visits for drug testing. |
| Secondary | Cannabinoid concentration - Saliva | through study completion, an average of 12 months | As well as measuring drug levels during treatment, these samples allow us to track the activity of the endocannabinoid system throughout the treatment. A novel approach to determine whether Delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD) function differently in the endocannabinoid system. |
| Secondary | TLFB | Administered at every study visit, besides fMRI scanning visits. | The Timeline Follow-Back (TLFB) will be used to record the time of cannabis use and route of administration as well as any alcohol and other drug use. |
| Secondary | Blood pressure | through study completion, an average of 12 months | Both systolic and diastolic pressure will be assessed |
| Secondary | Heart rate | Throughout the 12-month study | Heart rate (bpm) will be assessed |
| Secondary | Skin temperature | Throughout the 12-month study | Skin temperature (in degrees Fahrenheit) will be assessed |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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