Effects of Stress and Drug-cue Exposure (SCM)

Sponsor

Wayne State University (Other)

Overall Status

Recruiting

CT.gov ID

NCT03154567

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

0.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Marijuana Abuse	Drug: Yohimbine	Phase 1

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 Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Basic Science

Official Title:

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

Actual Study Start Date :

Nov 1, 2017

Anticipated Primary Completion Date :

Dec 1, 2021

Anticipated Study Completion Date :

Dec 1, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

Marijuana Craving Visual Analog Scale (VAS) (Self-report measure) [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) [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) [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) [Change is being assessed. Marijuana Rating Form is administered 30 minutes after each smoking episode in the sampling session.]
Marijuana Withdrawal Checklist [Change is being assessed. Questionnaire is administered every morning and evening.]
Subjective Effects Scale Visual Analog Scale (VAS) (Self-report measure) [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) [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) [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) [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) [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) [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.]

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 55 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tolan Park Medical Building	Detroit	Michigan	United States	48201

Sponsors and Collaborators

Wayne State University

Investigators

Principal Investigator: Leslie Lundahl, PhD, Wayne State University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Leslie Lundahl, Principal Investigator, Wayne State University

ClinicalTrials.gov Identifier:

NCT03154567

Other Study ID Numbers:

SCM-1

First Posted:

May 16, 2017

Last Update Posted:

Jul 2, 2021

Last Verified:

Jun 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

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.:

Additional relevant MeSH terms:

Marijuana Abuse

Yohimbine

Study Results

No Results Posted as of Jul 2, 2021