Effects of Stress and Drug-cue Exposure (SCM)

April 22, 2024 updated by: Leslie Lundahl, Wayne State University

Effects of Stress and Drug-cue Exposure on Craving and Marijuana Seeking Behavior in Regular Cannabis Smokers

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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).

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Tolan Park Medical Building

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Yohimbine 0mg X Cue Condition (neutral)
Drug: Yohimbine
Yohimbine (0mg, 20mg, or 40 mg) will be administered at 11:00am on each of the experimental sessions.
Placebo Comparator: Yohimbine 0mg X Cue Condition (marijuana)
Drug: Yohimbine
Yohimbine (0mg, 20mg, or 40 mg) will be administered at 11:00am on each of the experimental sessions.
Active Comparator: Yohimbine 20mg X Cue Condition (neutral)
Drug: Yohimbine
Yohimbine (0mg, 20mg, or 40 mg) will be administered at 11:00am on each of the experimental sessions.
Active Comparator: Yohimbine 20mg X Cue Condition (marijuana)
Drug: Yohimbine
Yohimbine (0mg, 20mg, or 40 mg) will be administered at 11:00am on each of the experimental sessions.
Active Comparator: Yohimbine 40mg X Cue Condition (neutral)
Drug: Yohimbine
Yohimbine (0mg, 20mg, or 40 mg) will be administered at 11:00am on each of the experimental sessions.
Active Comparator: Yohimbine 40mg X Cue Condition (marijuana)
Drug: Yohimbine
Yohimbine (0mg, 20mg, or 40 mg) will be administered at 11:00am on each of the experimental sessions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Marijuana Craving Visual Analog Scale (VAS) (Self-report measure)
Time Frame: Change is being assessed. Marijuana Craving VAS administered at baseline 0900. It will then be administered at 1000, 1030, 1100, 1200, 1220, 1245, 1300, 1315, 1345.
Change is being assessed. Marijuana Craving VAS administered at baseline 0900. It will then be administered at 1000, 1030, 1100, 1200, 1220, 1245, 1300, 1315, 1345.
Marijuana Craving Questionnaire (Self-report measure)
Time Frame: Change is being assessed. Marijuana Craving Quest.administered at baseline 0900. It will then be administered at 1000, 1030, 1100, 1200, 1410, 1430, 1500, 1530, 1600, 1630.
Change is being assessed. Marijuana Craving Quest.administered at baseline 0900. It will then be administered at 1000, 1030, 1100, 1200, 1410, 1430, 1500, 1530, 1600, 1630.
Questionnaire of Smoking Urges (Self-report measure)
Time Frame: Change is being assessed. Questionnaire is administered at baseline 0900. It will then be administered at 1000, 1030, 1100, 1200, 1410, 1430, 1500, 1530, 1600, 1630.
Change is being assessed. Questionnaire is administered at baseline 0900. It will then be administered at 1000, 1030, 1100, 1200, 1410, 1430, 1500, 1530, 1600, 1630.
Marijuana Rating Form (Self-report measure)
Time Frame: Change is being assessed. Marijuana Rating Form is administered 30 minutes after each smoking episode in the sampling session.
Change is being assessed. Marijuana Rating Form is administered 30 minutes after each smoking episode in the sampling session.
Marijuana Withdrawal Checklist
Time Frame: Change is being assessed. Questionnaire is administered every morning and evening.
Change is being assessed. Questionnaire is administered every morning and evening.
Subjective Effects Scale Visual Analog Scale (VAS) (Self-report measure)
Time Frame: Change is being assessed. Subjective Effects Scale administered at baseline 0900.It will then be administered at 1000, 1030, 1100, 1200, 1410, 1430, 1500, 1530, 1600, 1630.
Change is being assessed. Subjective Effects Scale administered at baseline 0900.It will then be administered at 1000, 1030, 1100, 1200, 1410, 1430, 1500, 1530, 1600, 1630.
Positive & Negative Affect Schedule (Self-report measure)
Time Frame: Change is being assessed. Questionnaire is administered at baseline 0900. It will then be administered at 1000, 1030, 1100, 1200, 1410, 1430, 1500, 1530, 1600, 1630.
Change is being assessed. Questionnaire is administered at baseline 0900. It will then be administered at 1000, 1030, 1100, 1200, 1410, 1430, 1500, 1530, 1600, 1630.
Systolic blood pressure (physiological effects)
Time Frame: Change is being assessed. Systolic blood pressure measured at baseline 0900. It will then be measure at 1000, 1030, 1100, 1200, 1410, 1430, 1500, 1530, 1600, 1630.
Change is being assessed. Systolic blood pressure measured at baseline 0900. It will then be measure at 1000, 1030, 1100, 1200, 1410, 1430, 1500, 1530, 1600, 1630.
Diastolic blood pressure (physiological effects)
Time Frame: Change is being assessed. Diastolic blood pressure measured at baseline 0900. It will then be measure at 1000, 1030, 1100, 1200, 1410, 1430, 1500, 1530, 1600, 1630.
Change is being assessed. Diastolic blood pressure measured at baseline 0900. It will then be measure at 1000, 1030, 1100, 1200, 1410, 1430, 1500, 1530, 1600, 1630.
Heart rate (physiological effects)
Time Frame: Change is being assessed. Heart rate measured at baseline 0900. It will then be measure at 1000, 1030, 1100, 1200, 1410, 1430, 1500, 1530, 1600, 1630.
Change is being assessed. Heart rate measured at baseline 0900. It will then be measure at 1000, 1030, 1100, 1200, 1410, 1430, 1500, 1530, 1600, 1630.
Core-body temperature (physiological effects)
Time Frame: Change is being assessed. Core-body temperature measured at baseline 0900. It will then be measure at 1000, 1030, 1100, 1200, 1410, 1430, 1500, 1530, 1600, 1630.
Change is being assessed. Core-body temperature measured at baseline 0900. It will then be measure at 1000, 1030, 1100, 1200, 1410, 1430, 1500, 1530, 1600, 1630.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wayne State University

Investigators

  • Principal Investigator: Leslie Lundahl, PhD, Wayne State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2017

Primary Completion (Actual)

October 27, 2023

Study Completion (Actual)

October 27, 2023

Study Registration Dates

First Submitted

April 25, 2017

First Submitted That Met QC Criteria

May 12, 2017

First Posted (Actual)

May 16, 2017

Study Record Updates

Last Update Posted (Actual)

April 23, 2024

Last Update Submitted That Met QC Criteria

April 22, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCM-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Marijuana Abuse

Clinical Trials on Yohimbine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ecuador

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe