Effectiveness Study of Dronabinol and BRENDA for the Treatment of Cannabis Withdrawal (NCT00480441) | Clinical Trial Compass
CompletedPhase 2
Effectiveness Study of Dronabinol and BRENDA for the Treatment of Cannabis Withdrawal
United States61 participantsStarted 2006-08
Plain-language summary
This treatment study is targeted specifically for those who want to stop using marijuana. We want to find out if patients who are dependent on marijuana and want to stop using are helped by a combination of the drug dronabinol and six sessions of individual therapy (BRENDA). Dronabinol is a pill form of the active ingredient in marijuana (THC). Currently, dronabinol is approved for the treatment of nausea in people receiving cancer chemotherapy and as an appetite stimulant in people with AIDS.
In some studies, dronabinol reduced the amount of psychological and physical discomfort experienced when people stopped using marijuana. One purpose of our study is to see if people who are on dronabinol have fewer problems with psychological and physical discomfort than those who are on a placebo.
In addition to treatment, this research trial will also be measuring the reactions of subjects to drug-related cues, and also to computer-presented tasks unrelated to drug use. We may examine whether the response to these cues/tasks either predicts treatment outcome, or is affected by your treatment. This information may also help us to understand the ways in which chronic drug use causes changes in our subjects' mental functioning and how those changes respond to treatment.
In addition to participation in the treatment research trial, some subjects may be asked to undergo a brain scan in an MRI. The purpose of the brain scan research project is to measure brain reactions with a non-invasive, non-radioactive imaging technique known as fMRI (functional magnetic resonance imaging) in marijuana subjects before and after treatment with the medication dronabinol or with an inactive substance (placebo).
Who can participate
Age range
18 Years – 55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Males and females, 18-55 years old
. Meets DSM-IV criteria for Cannabis Dependence
. History of chronic cannabis use of moderate intensity defined by 10 or more years of use with an average frequency of 2 or more joints/day on 5 or more days/week
. Live within a commutable distance of the Treatment Research Center
. Understand and sign the informed consent
. Voluntarily seeking treatment for cannabis dependence
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Physiological Changes in Response to Cue-induced Craving.
Timeframe: Baseline functional mri (fMRI), (prior to randomization)
. Current DSM-IV diagnosis of any psychoactive substance dependence other than marijuana, or nicotine dependence
. Concomitant treatment with sedative hypnotics, opioid analgesics or other known CNS depressants at a dose and frequency that is unacceptable to the principal investigator
. Mandated to treatment based upon a legal decision or as a condition of employment
. Current severe psychiatric symptoms, e.g. psychosis, dementia, acute suicidal or homicidal ideation, mania or depression requiring antidepressant therapy, or which could make it unsafe for the patient to participate in the opinion of the primary investigators
. History of significant, unstable heart disease, including myocardial infarction, unstable angina, cardiac failure, second or third degree heart block, uncontrolled hypertension, syncope
. Known hypersensitivity to cannabinoids or sesame oil
. Any serious medical illness, which may require hospitalization during the study (i.e. sickle cell anemia, rheumatoid arthritis)
. Has any disease of the gastrointestinal system, liver or kidneys which could result in altered metabolism or excretion of the study medication (history of major gastrointestinal tract surgery, gastrectomy, gastrotomy, bowel resection, etc.) or history of chronic gastrointestinal disorders (ulcerative colitis, regional enteritis, or gastrointestinal bleeding)