Effects of Drugs on Stress Memories

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-01

Study Completion Date

2025-03-25

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Delta-9-tetrahydrocannabinol (THC) Stress

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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placebo

Dextrose capsules

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo - dextrose

5 mg delta-9-tetrahydrocannabinol (THC)

Marinol (dronabinol)

Group Type EXPERIMENTAL

delta-9-tetrahydrocannabinol (THC) (5)

Intervention Type DRUG

5 mg of THC

10 mg delta-9-tetrahydrocannabinol (THC)

Marinol (dronabinol)

Group Type EXPERIMENTAL

delta-9-tetrahydrocannabinol (THC) (10)

Intervention Type DRUG

10 mg of THC

Interventions

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delta-9-tetrahydrocannabinol (THC) (5)

5 mg of THC

Intervention Type DRUG

Placebo

Placebo - dextrose

Intervention Type DRUG

delta-9-tetrahydrocannabinol (THC) (10)

10 mg of THC

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes