Effects of Stress and Drug-cue Exposure (SCM)

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

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-01

Study Completion Date

2023-10-27

Brief Summary

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The purpose of the proposed study to examine the links among stress, craving for marijuana, and marijuana reminders, or "cues".

In this study, an agent called yohimbine will be used to produce stress-like responses. Yohimbine is known to cause stress response in studies of alcohol and other substance use disorders. This study intends to show it can be used to cause stress in marijuana users as well.

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Detailed Description

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Part of this study will be conducted on a residential unit where participants will live for 7 nights over a 2-week period (4 consecutive nights the 1st week and 3 consecutive nights the 2nd week).

During that time, participants can't leave the unit unescorted or have visitors.

During the inpatient stay participants will participant in experimental sessions where they will be asked to smoke cigarettes containing either marijuana or placebo (a blank).

Participants will be asked to take capsules that could contain yohimbine or placebo (blank).

Participants will be asked to complete questionnaires and will have their vital signs (blood pressure, heart rate) monitored throughout each session.

Participants will be asked to participate in overnight sleep recordings, a polysomnogram (PSG).

Conditions

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Marijuana Abuse

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

* Participants (18-55 yr) will be current marijuana users, based on self-report and THC-positive urine samples.
* Candidates must meet DSM-5 criteria for Mild-to-Moderate Cannabis Use Disorder (CUD) and be willing to participate in research but not seeking treatment.
* Candidates must be in good health, as assessed using data from psychiatric evaluation, extensive substance use history interview, and medical evaluations including medical history, physical exam, standard lab tests and 12-lead ECG.

Exclusion Criteria

Candidates with the following conditions will be excluded:

* Serious psychiatric illness (e.g. psychotic or bipolar disorder, recent suicide attempts, major depression).
* Substance Use Disorders other than Cannabis or Nicotine Use Disorders and Mild Alcohol Use Disorder.
* Neurological diseases
* Cardiovascular problems (e.g. including systolic BP \>140 or \<95 mmHg, diastolic BP \>90 mmHg, abnormal ECG).
* Pulmonary diseases
* Systemic diseases
* Cognitive impairment (\<80 IQ)
* Past-month medications that increase study risk.
* Women who are pregnant, lactating, or if heterosexually active and not using medically approved birth control.
* Candidates seeking Substance Use Disorder treatment.
* Individuals unable to give voluntary informed consent will be excluded.

Minimum Eligible Age

21 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No