Effects of Stress and Drug-cue Exposure (SCM)

NCT03154567 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: SCM-1
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Marijuana Abuse

Outcome Measures

Primary Outcomes (11)

• 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.

Study Arms (6)

Yohimbine 0mg X Cue Condition (neutral)

PLACEBO COMPARATOR

Drug: Yohimbine

Yohimbine 0mg X Cue Condition (marijuana)

PLACEBO COMPARATOR

Drug: Yohimbine

Yohimbine 20mg X Cue Condition (neutral)

ACTIVE COMPARATOR

Drug: Yohimbine

Yohimbine 20mg X Cue Condition (marijuana)

ACTIVE COMPARATOR

Drug: Yohimbine

Yohimbine 40mg X Cue Condition (neutral)

ACTIVE COMPARATOR

Drug: Yohimbine

Yohimbine 40mg X Cue Condition (marijuana)

ACTIVE COMPARATOR

Drug: Yohimbine

Interventions

Yohimbine DRUG

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

Yohimbine 0mg X Cue Condition (marijuana); Yohimbine 0mg X Cue Condition (neutral); Yohimbine 20mg X Cue Condition (marijuana); Yohimbine 20mg X Cue Condition (neutral); Yohimbine 40mg X Cue Condition (marijuana); Yohimbine 40mg X Cue Condition (neutral)

Eligibility Criteria

• Age: 21 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wayne State University: lead

Study Sites (1)

Tolan Park Medical Building

Detroit, Michigan, 48201, United States

Location

MeSH Terms

Conditions

Marijuana Abuse

Interventions

Yohimbine

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines

Study Officials

• Leslie Lundahl, PhD

  Wayne State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 25, 2017
• First Posted: May 16, 2017
• Study Start: November 1, 2017
• Primary Completion: October 27, 2023
• Study Completion: October 27, 2023
• Last Updated: April 23, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)