Effects of Drugs on Stress Memories (ETS)

The University of Chicago

Status and phase: Completed; Early Phase 1

Conditions: Delta-9-tetrahydrocannabinol (THC); Stress

Treatments: Drug: Placebo; Drug: delta-9-tetrahydrocannabinol (THC) (5); Drug: delta-9-tetrahydrocannabinol (THC) (10)

Study type: Interventional

Funder types: Other

Identifiers

NCT06471647

IRB23-1534

Details and patient eligibility

About

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.

Full 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.

Enrollment: 36 patients

Sex: All

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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36 participants in 3 patient groups, including a placebo group

placebo

Placebo Comparator group

Description:

Dextrose capsules

Treatment:

Drug: Placebo

5 mg delta-9-tetrahydrocannabinol (THC)

Experimental group

Description:

Marinol (dronabinol)

Treatment:

Drug: delta-9-tetrahydrocannabinol (THC) (5)

10 mg delta-9-tetrahydrocannabinol (THC)

Experimental group

Description:

Marinol (dronabinol)

Treatment:

Drug: delta-9-tetrahydrocannabinol (THC) (10)