Delta-9-tetrahydrocannabinol (THC), Stress
Conditions
Brief summary
There is evidence that cannabinoids, including delta-9-tetrahydrocannabinol (THC), reduce responses to acute stress and fear-related stimuli, but few studies have examined the effects of THC on memories of stressful experiences. The researchers hypothesize that THC will attenuate behavioral and physiological responses to negative valence stimuli, including memories of aversive experiences.
Detailed description
The current study will use a between subject, randomized, placebo-controlled design to assess the effects of low doses of delta-9-tetrahydrocannabinol (THC) on stress memories. Healthy male and female participants (N=48) will be randomly assigned to one of the three drug conditions (5 mg THC \[n=16\], 10 mg THC \[n=16\], or placebo \[n=16\]). Each subject will participate in 3 sessions. In the first session, they will undergo the TSST procedure. Researchers will obtain ratings of subjective distress, heart rate variability, and cortisol levels to assess response to the stressor for each individual. On the second session, one week later, participants will receive either THC or placebo and they will then be presented with TSST-related cues during a stress-memory retrieval session.
Interventions
DRUGdelta-9-tetrahydrocannabinol (THC) (5)
5 mg of THC
DRUGPlacebo
Placebo - dextrose
DRUGdelta-9-tetrahydrocannabinol (THC) (10)
10 mg of THC
Sponsors
University of Chicago
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
Yes
Inclusion criteria
* 18-35 y/o * BMI 19-29 kg/m2 * some prior experience with cannabis (used at least 4 times, no adverse experiences, and current use no more than once a week)
Exclusion criteria
* Current severe substance use disorder * history of psychosis or mania * Lack of English fluency * Current DSM IV Axis I disorder * Abnormal EKG * Daily use of medications outside of contraception, * Women who are pregnant or trying to become pregnant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Emotional Responses After Stress Memory Cues Compared to Control Cues After Delta-9-tetrahydrocannabinol (THC) (5 mg, 10 mg) vs. Placebo | 20 seconds after each cue presentation during the task | Using a visual analog scale participants will rate feelings of 'distress' 'arousal' and 'valence'. Scores range from 0-100 with higher scores indicating greater responses on particular items |
| Mean Physiological Responses After Stress Memory Cue Presentation Compared to Control Cues | difference between values during 20 seconds of task cue presentations | Researchers will assess changes in cardiac output (pre-ejection period) after presentation of cues. This will be measured in milliseconds. Lower values indicate greater sympathetic activation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Emotional Responses One Week Later During Non-drug Retrieval Session | 1 week after the first exposure they will complete the memory task again. The timeframe for assessing mean emotional responses will be at baseline (5 minutes pre-memory task) and 20 seconds after each cue presentation | Using a visual analog scale from 0-100 participants will rate feelings of 'distress' 'arousal' and 'valence' in a non-drug state. Scores range from 0-100 with higher scores indicating greater responses on particular items |
| Mean Negative Facial Emotion Expressions During Cue Presentation After THC (5 and 10 mg) vs Placebo | During 20 seconds cue presentation | Using facial expression model, researchers will assess changes in the intensity (0-1) of negative facial emotions during presentation of memory cues, comparing control vs. stress memory cues. higher values indicate greater intensity. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORHarriet de Wit
University of Chicago
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 36 Participants |
| Age, Continuous | 26.4 years STANDARD_DEVIATION 4.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 11 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 5 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 21 Participants |
| Region of Enrollment United States | 36 participants |
| Sex: Female, Male Female | 19 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 12 | 0 / 12 |
| other Total, other adverse events | 0 / 12 | 0 / 12 | 0 / 12 |
| serious Total, serious adverse events | 0 / 12 | 0 / 12 | 0 / 12 |
Outcome results
None listed