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Effects of Stress and Drug-cue Exposure (SCM)

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ClinicalTrials.gov Identifier: NCT03154567
Recruitment Status : Recruiting
First Posted : May 16, 2017
Last Update Posted : July 18, 2019
Sponsor:
Information provided by (Responsible Party):
Leslie Lundahl, Wayne State University

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).


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Study Type : Interventional  (Clinical Trial)
Estimated 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 : November 1, 2017
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Marijuana

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.




Primary Outcome Measures :
  1. 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. ]
  2. 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. ]
  3. 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. ]
  4. 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. ]
  5. Marijuana Withdrawal Checklist [ Time Frame: Change is being assessed. Questionnaire is administered every morning and evening. ]
  6. 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. ]
  7. 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. ]
  8. 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. ]
  9. 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. ]
  10. 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. ]
  11. 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. ]


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03154567


Contacts
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Contact: Alina Woodford (313) 993-3960 awoodford@med.wayne.edu

Locations
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United States, Michigan
Tolan Park Medical Building Recruiting
Detroit, Michigan, United States, 48201
Contact: Leslie Lundahl, PhD         
Sponsors and Collaborators
Wayne State University
Investigators
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Principal Investigator: Leslie Lundahl, PhD Wayne State University

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Responsible Party: Leslie Lundahl, Principal Investigator, Wayne State University
ClinicalTrials.gov Identifier: NCT03154567     History of Changes
Other Study ID Numbers: SCM-1
First Posted: May 16, 2017    Key Record Dates
Last Update Posted: July 18, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Marijuana Abuse
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Yohimbine
Mydriatics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic alpha-2 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Urological Agents