Marijuana AbuseDDCNCT00943930
Marijuana Drug Discrimination and Self-Administration
An observational study of Marijuana Abuse, run by Wayne State University at 1 site in United States.
Trial summary
This study is designed to investigate the associations among marijuana's discriminative stimulus, reinforcing, subjective (e.g. craving) and physiological effects, and to assess the relative ability of oral THC to block these effects. Read more about this study
- Who is it for?
- Ages 21 to 45 years
- Conditions the study is for
- Marijuana Abuse
- What is being tested?
- THC (delta-9 tetrahydrocannabinol), d-amphetamine, oral THC
- Type of treatment
- Pill or oral medicine
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2009to Dec 2014
- Phase
- Observational
- 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 45 years
- All sexes
- No healthy volunteers
- Adult
Study population: Marijuana dependent volunteers
Who may be able to join
- Female and male volunteers must be in generally good health (as indicated by results from medical history, physical exam, electrocardiogram, urine and blood samples at screening and upon arrival at the laboratory (urine samples only).
- Psychiatric examination must meet DSM-IV criteria for Cannabis Dependence.
- Individuals must be legally and mentally competent to provide written informed consent.
- Those who are unable to give their voluntary informed consent will not be accepted.
Who cannot join
- Current serious Axis I disorder (except Cannabis or Nicotine Dependence), neurologic, cardiovascular, pulmonary or systemic (e.g., renal, hepatic) disease; cognitive impairment; pregnancy (urine test), lactation (self-report), or not using (self-report) medically approved contraceptives.
- Applicants who express interest in treatment will not be accepted for study and will be provided with a treatment referral.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Smoked Marijuana Discrimination and Marijuana Choice in Humans: A Laboratory Mode
This study is designed to investigate the associations among marijuana's discriminative stimulus, reinforcing, subjective (e.g. craving) and physiological effects, and to assess the relative ability of oral THC to block these effects.
Read the detailed description
Volunteers will be asked to live on a research unit for up to twenty-six (26) consecutive nights and will participate in a total of 38 study sessions held on 19 weekdays. Each session will last approximately four hours and there will be two sessions per day, therefore each study day will last approximately eight hours. In addition to these study sessions, an orientation session will be conducted on the Friday prior to admission to the inpatient unit, and a lottery session will be held on the last day of the study.
During each study session participants will be asked to smoke a cigarette. The cigarette may contain marijuana or it may contain placebo (a blank). Participants will also be asked to swallow a capsule 2-hours prior to smoking the cigarette. The capsule could contain placebo (a blank), THC (delta-9 tetrahydrocannabinol, which is the active ingredient in marijuana responsible for its mood effects), or d-amphetamine. We will have participants answer questions about how the drugs make them feel and measure their vitals signs (blood pressure, heart rate, and oxygen saturation) will be measured using a non-invasive (external) vitals monitor.
- Conditions
- Marijuana Abuse
- Being tested
- THC (delta-9 tetrahydrocannabinol), d-amphetamine, oral THC
- Medical subject headings
- Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
THC (delta-9 tetrahydrocannabinol), d-amphetamine, oral THCDrug
During each study session participants will be asked to smoke a cigarette. The cigarette may contain marijuana or it may contain placebo (a blank). Participants will also be asked to swallow a capsule 2-hours prior to smoking the cigarette. The capsule could contain placebo (a blank), THC (delta-9 tetrahydrocannabinol, or d-amphetamine.
| Study group | Role | What they receive |
|---|---|---|
| Marijuana-dependent volunteers | Not described Receives: Drug: THC (delta-9 tetrahydrocannabinol), d-amphetamine, oral THC |
What is being measured
The primary outcome is the main question the study is designed to answer.
To test the ability of oral THC to alter the discriminative stimulus and reinforcing effects of smoked marijuana.
Three hours after each smoked marijuana dose the participant will complete the MCP-Q to make 15 independent choices between the drug dose sampled and various money amounts.
Measured: Multiple Choice Procedure Questionnaire (MCP-Q) will be administered after each drug administration sessions and participants will choose between the drug and various amounts of money.
Secondary outcomes (1)
Subjective effects: Self-report questionnaires regarding subjective drug effects, craving, withdrawal symptoms, and marijuana choice will be assessed. Physiological effects: Heart rate, skin temperature, and blood pressure will be monitored.
Measured: Measurements will be taken throughout a total of 40 sessions (i.e., two sessions per day) conducted over 20 weekdays. Total duration of the stay will be up to 30 days, as sessions will not be run on weekends.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2009 (estimated)
- Study startApr 2009
- Primary completionDec 2012
- Study completionDec 2014
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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wayne State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- 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
- NCT00943930
- Sponsor's protocol ID
- NIDA DA026761
- Other IDs
- R01DA026761-01
- Acronym
- DDC
- Status last verified
- Apr 2016
- First submitted
- 21 Jul 2009
- Last updated
- 28 Apr 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smoked Marijuana Discrimination and Marijuana Choice in Humans: A Laboratory Mode
- ClinicalTrials.gov ID
- NCT00943930
- Acronym / sponsor ID
- DDC / NIDA DA026761
- Conditions
- Marijuana Abuse
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Wayne State UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Apr 2009
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 22 Jul 2009 (estimated)
- 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.
This study is designed to investigate the associations among marijuana's discriminative stimulus, reinforcing, subjective (e.g. craving) and physiological effects, and to assess the relative ability of oral THC to block these effects.
Detailed description
Volunteers will be asked to live on a research unit for up to twenty-six (26) consecutive nights and will participate in a total of 38 study sessions held on 19 weekdays. Each session will last approximately four hours and there will be two sessions per day, therefore each study day will last approximately eight hours. In addition to these study sessions, an orientation session will be conducted on the Friday prior to admission to the inpatient unit, and a lottery session will be held on the last day of the study.
During each study session participants will be asked to smoke a cigarette. The cigarette may contain marijuana or it may contain placebo (a blank). Participants will also be asked to swallow a capsule 2-hours prior to smoking the cigarette. The capsule could contain placebo (a blank), THC (delta-9 tetrahydrocannabinol, which is the active ingredient in marijuana responsible for its mood effects), or d-amphetamine. We will have participants answer questions about how the drugs make them feel and measure their vitals signs (blood pressure, heart rate, and oxygen saturation) will be measured using a non-invasive (external) vitals monitor.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Marijuana-dependent volunteers | – | Drug: THC (delta-9 tetrahydrocannabinol), d-amphetamine, oral THC |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Marijuana dependent volunteers
Key inclusion criteria (4 listed)
- Female and male volunteers must be in generally good health (as indicated by results from medical history, physical exam, electrocardiogram, urine and blood samples at screening and upon arrival at the laboratory (urine samples only).
- Psychiatric examination must meet DSM-IV criteria for Cannabis Dependence.
- Individuals must be legally and mentally competent to provide written informed consent.
- Those who are unable to give their voluntary informed consent will not be accepted.
Key exclusion criteria (2 listed)
- Current serious Axis I disorder (except Cannabis or Nicotine Dependence), neurologic, cardiovascular, pulmonary or systemic (e.g., renal, hepatic) disease; cognitive impairment; pregnancy (urine test), lactation (self-report), or not using (self-report) medically approved contraceptives.
- Applicants who express interest in treatment will not be accepted for study and will be provided with a treatment referral.
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 |
|---|---|---|
| THC (delta-9 tetrahydrocannabinol), d-amphetamine, oral THCDuring each study session participants will be asked to smoke a cigarette. The cigarette may contain marijuana or it may contain placebo (a blank). Participants will also be asked to swallow a capsule 2-hours prior to smoking the cigarette. The capsule could contain placebo (a blank), THC (delta-9 tetrahydrocannabinol, or d-amphetamine. | Drug | Marijuana-dependent volunteers |
Primary outcome
To test the ability of oral THC to alter the discriminative stimulus and reinforcing effects of smoked marijuana.
Time frame: Multiple Choice Procedure Questionnaire (MCP-Q) will be administered after each drug administration sessions and participants will choose between the drug and various amounts of money.
Three hours after each smoked marijuana dose the participant will complete the MCP-Q to make 15 independent choices between the drug dose sampled and various money amounts.
1 secondary outcome
Subjective effects: Self-report questionnaires regarding subjective drug effects, craving, withdrawal symptoms, and marijuana choice will be assessed. Physiological effects: Heart rate, skin temperature, and blood pressure will be monitored.
Time frame: Measurements will be taken throughout a total of 40 sessions (i.e., two sessions per day) conducted over 20 weekdays. Total duration of the stay will be up to 30 days, as sessions will not be run on weekends.
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 28 Apr 2016.
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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?
An observational study of 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 4 inclusion and 2 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 28 Apr 2016. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
To test the ability of oral THC to alter the discriminative stimulus and reinforcing effects of smoked marijuana. (time frame: Multiple Choice Procedure Questionnaire (MCP-Q) will be administered after each drug administration sessions and participants will choose between the drug and various amounts of money.). 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 28 Apr 2016.