Effects of Stress and Drug-cue Exposure (SCM)

Wayne State University

Status and phase: Completed; Phase 1

Conditions: Marijuana Abuse

Treatments: Drug: Yohimbine

Study type: Interventional

Funder types: Other

Identifiers

NCT03154567

SCM-1

Details and patient eligibility

About

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.

Full 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).

Enrollment: 12 patients

Sex: All

Ages: 21 to 55 years old

Volunteers: No 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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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12 participants in 6 patient groups, including a placebo group

Yohimbine 0mg X Cue Condition (neutral)

Placebo Comparator group

Treatment:

Drug: Yohimbine

Yohimbine 0mg X Cue Condition (marijuana)

Placebo Comparator group

Treatment:

Drug: Yohimbine

Yohimbine 20mg X Cue Condition (neutral)

Active Comparator group

Treatment:

Drug: Yohimbine

Yohimbine 20mg X Cue Condition (marijuana)

Active Comparator group

Treatment:

Drug: Yohimbine

Yohimbine 40mg X Cue Condition (neutral)

Active Comparator group

Treatment:

Drug: Yohimbine

Yohimbine 40mg X Cue Condition (marijuana)

Active Comparator group

Treatment:

Drug: Yohimbine