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Effects of Stress and Drug-cue Exposure (SCM)

Primary Purpose

Marijuana Abuse

Status

Unknown status

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Yohimbine

About this trial

This is an interventional basic science trial for Marijuana Abuse

Eligibility Criteria

21 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Tolan Park Medical BuildingRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Yohimbine 0mg X Cue Condition (neutral)

Yohimbine 0mg X Cue Condition (marijuana)

Yohimbine 20mg X Cue Condition (neutral)

Yohimbine 20mg X Cue Condition (marijuana)

Yohimbine 40mg X Cue Condition (neutral)

Yohimbine 40mg X Cue Condition (marijuana)

Arm Description

Outcomes

Primary Outcome Measures

Marijuana Craving Visual Analog Scale (VAS) (Self-report measure)

Marijuana Craving Questionnaire (Self-report measure)

Questionnaire of Smoking Urges (Self-report measure)

Marijuana Rating Form (Self-report measure)

Marijuana Withdrawal Checklist

Subjective Effects Scale Visual Analog Scale (VAS) (Self-report measure)

Positive & Negative Affect Schedule (Self-report measure)

Systolic blood pressure (physiological effects)

Diastolic blood pressure (physiological effects)

Heart rate (physiological effects)

Core-body temperature (physiological effects)

Secondary Outcome Measures

Full Information

NCT ID

NCT03154567

First Posted

April 25, 2017

Last Updated

June 30, 2021

Sponsor

Wayne State University

1. Study Identification

Unique Protocol Identification Number

NCT03154567

Brief Title

Effects of Stress and Drug-cue Exposure (SCM)

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2021

Overall Recruitment Status

Unknown status

Study Start Date

November 1, 2017 (Actual)

Primary Completion Date

December 2021 (Anticipated)

Study Completion Date

December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Wayne State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Marijuana Abuse

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Yohimbine 0mg X Cue Condition (neutral)

Arm Type

Placebo Comparator

Arm Title

Yohimbine 0mg X Cue Condition (marijuana)

Arm Type

Placebo Comparator

Arm Title

Yohimbine 20mg X Cue Condition (neutral)

Arm Type

Active Comparator

Arm Title

Yohimbine 20mg X Cue Condition (marijuana)

Arm Type

Active Comparator

Arm Title

Yohimbine 40mg X Cue Condition (neutral)

Arm Type

Active Comparator

Arm Title

Yohimbine 40mg X Cue Condition (marijuana)

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

Yohimbine

Intervention Description

Yohimbine (0mg, 20mg, or 40 mg) will be administered at 11:00am on each of the experimental sessions.

Primary Outcome Measure Information:

Title

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.

Title

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.

Title

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.

Title

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.

Title

Marijuana Withdrawal Checklist

Time Frame

Change is being assessed. Questionnaire is administered every morning and evening.

Title

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.

Title

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.

Title

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.

Title

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.

Title

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.

Title

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.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Leslie Lundahl

Phone

(313) 993-3960

llundahl@med.wayne.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Leslie Lundahl, PhD

Organizational Affiliation

Wayne State University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Tolan Park Medical Building

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48201

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Leslie Lundahl, PhD

12. IPD Sharing Statement

Plan to Share IPD

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Effects of Stress and Drug-cue Exposure (SCM)

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