Marijuana AbusePhase 1NCT03154567
Effects of Stress and Drug-cue Exposure (SCM)
A Phase 1 study testing Yohimbine in people with Marijuana Abuse, run by Wayne State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 55 years
- Conditions the study is for
- Marijuana Abuse
- What is being tested?
- Yohimbine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2017to 27 Oct 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 12Show fewer
- 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 locations and contacts
1 site in 1 country.
United States1 site
Tolan Park Medical Building
Detroit, Michigan, 48201
About this study
Official title: Effects of Stress and Drug-cue Exposure on Craving and Marijuana Seeking Behavior in Regular Cannabis Smokers
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.
Read the 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).
- Conditions
- Marijuana Abuse
- Being tested
- Yohimbine
- Medical subject headings
- Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YohimbineDrug
Yohimbine (0mg, 20mg, or 40 mg) will be administered at 11:00am on each of the experimental sessions.
| Study group | Role | What they receive |
|---|---|---|
| Yohimbine 0mg X Cue Condition (neutral) | Placebo comparator | Not described Receives: Drug: Yohimbine |
| Yohimbine 0mg X Cue Condition (marijuana) | Placebo comparator | Not described Receives: Drug: Yohimbine |
| Yohimbine 20mg X Cue Condition (neutral) | Active comparator | Not described Receives: Drug: Yohimbine |
| Yohimbine 20mg X Cue Condition (marijuana) | Active comparator | Not described Receives: Drug: Yohimbine |
| Yohimbine 40mg X Cue Condition (neutral) | Active comparator | Not described Receives: Drug: Yohimbine |
| Yohimbine 40mg X Cue Condition (marijuana) | Active comparator | Not described Receives: Drug: Yohimbine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Marijuana Craving Visual Analog Scale (VAS) (Self-report measure)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: Change is being assessed. Marijuana Rating Form is administered 30 minutes after each smoking episode in the sampling session.
Marijuana Withdrawal Checklist
Measured: Change is being assessed. Questionnaire is administered every morning and evening.
Subjective Effects Scale Visual Analog Scale (VAS) (Self-report measure)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2017
- Study start1 Nov 2017
- Primary completion27 Oct 2023
- Study completion27 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Marijuana AbuseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wayne State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leslie Lundahl, Wayne State University
- Investigators
- Leslie Lundahl, PhD, Principal investigator, Wayne State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03154567
- Sponsor's protocol ID
- SCM-1
- Status last verified
- Apr 2024
- First submitted
- 25 Apr 2017
- Last updated
- 23 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Stress and Drug-cue Exposure on Craving and Marijuana Seeking Behavior in Regular Cannabis Smokers
- ClinicalTrials.gov ID
- NCT03154567
- Acronym / sponsor ID
- SCM-1
- Conditions
- Marijuana Abuse
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Wayne State UniversityUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 27 Oct 2023 (actual)
- Study completion
- 27 Oct 2023 (actual)
- First posted
- 16 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| YohimbineYohimbine (0mg, 20mg, or 40 mg) will be administered at 11:00am on each of the experimental sessions. | Drug | 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) |
Primary outcome
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.
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.
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.
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.
Marijuana Withdrawal Checklist
Time frame: Change is being assessed. Questionnaire is administered every morning and evening.
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.
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.
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leslie Lundahl, PhD principal investigator
Wayne State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Yohimbine in people with Marijuana Abuse, run by Wayne State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2024.