NEWS HIGHLIGHTS
Published Studies Related to Marinol (Dronabinol)
Efficacy of Dronabinol as an Adjuvant Treatment for Chronic Pain Patients on Opioid Therapy. [2008.03]
We assessed the efficacy of dronabinol (Marinol capsules; Solvay Pharmaceuticals, Brussels, Belgium), a synthetic Delta(9)-THC (tetrahydrocannabinol), in 30 patients taking opioids for chronic pain to determine its potential analgesic effects as an adjuvant treatment...
Patients with chronic pain on opioid therapy taking dronabinol: incidence of false negatives using radioimmunoassay. [2008.01]
BACKGROUND: Serum blood toxicology screens are believed to be important to monitor compliance and to identify levels of illicit substances in patients taking opioids for their chronic pain... CONCLUSIONS: These toxicology reports point to higher than anticipatedfalse-negative results with radioimmunoassay blood serum screening. Results could be explained by the lower sensitivity of this screening technique and also in how oral cannabinoids are metabolized. Further investigations are needed on the accuracy of the detection of THC among patients known to have used dronabinol.
Efficacy of Dronabinol as an Adjuvant Treatment for Chronic Pain Patients on Opioid Therapy. [2007.12.12]
We assessed the efficacy of dronabinol (Marinol capsules; Solvay Pharmaceuticals, Brussels, Belgium), a synthetic Delta(9)-THC (tetrahydrocannabinol), in 30 patients taking opioids for chronic pain to determine its potential analgesic effects as an adjuvant treatment...
Dronabinol and marijuana in HIV-positive marijuana smokers. Caloric intake, mood, and sleep. [2007.08.15]
OBJECTIVES: Individuals with HIV constitute the largest group using cannabinoids for medicinal reasons; yet, no studies have directly compared the tolerability and efficacy of smoked marijuana and oral dronabinol maintenance in HIV-positive marijuana smokers. This placebo-controlled within-subjects study evaluated marijuana and dronabinol across a range of behaviors: eating topography, mood, cognitive performance, physiologic measures, and sleep... CONCLUSIONS: These data suggest that for HIV-positive marijuana smokers, both dronabinol (at doses 8 times current recommendations) and marijuana were well tolerated and produced substantial and comparable increases in food intake.
Efficacy of dronabinol alone and in combination with ondansetron versus ondansetron alone for delayed chemotherapy-induced nausea and vomiting. [2007.03]
CONCLUSIONS: Dronabinol or ondansetron was similarly effective for the treatment of CINV. Combination therapy with dronabinol and ondansetron was not more effective than either agent alone. Active treatments were well tolerated.
Clinical Trials Related to Marinol (Dronabinol)
Study to Evaluate the Efficacy of Dronabinol (Marinol) as Add-On Therapy for Patients on Opioids for Chronic Pain [Active, not recruiting]
The purpose of this research study is to determine if Marinol alleviates pain in patients
with chronic pain who are currently taking opioids.
The study begins with a 2-hour initial visit followed by three 8-hour appointments at Brigham
and Women’s Hospital. At each 8-hour visit, patients receive a dose of medication and
complete surveys relating to pain.
During the first visit a brief examination and a few surveys about pain, quality of life, and
medical history are given. The study doctor then determines if the participant continues to
qualify for the study.
If qualified for the study, patients receive a daily diary to record pain levels and pain
medications; this will take about 5 minutes each day. After completion of the diary,
patients begin the 8-hour visits.
Patients visit the Pain Trials Center three times to receive study medication. After taking
the study medication, participants remain in the clinic for 8 hours to complete hourly
surveys about pain and pain relief.
Subsequent to these visits, patients may enter a 1-month extension where Marinol is taken at
home, and pain levels are recorded in a diary. Participants can change the dose of study drug
to better control pain and side effects, after speaking with study staff. The study then
concludes with a final 30-minute visit to summarize the participant’s experience in the
clinical trial.
Ph1 Marinol Interaction Study - Part 1 - 1 [Active, not recruiting]
The purpose of this study is to examine the effects of oral dronabinol tetrahydrocannabinol
(THC) on withdrawal symptoms in marijuana dependent volunteers, and evaluate the safety,
pharmacokinetics (PK), and cardiovascular effects of the combination of oral dronabinol and
smoked marijuana to determine if there are potential significant interactions before
conducting outpatient studies.
Effectiveness Study of Dronabinol and BRENDA for the Treatment of Cannabis Withdrawal [Recruiting]
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).
Dronabinol Treatment for Marijuana Addiction [Recruiting]
The purpose of this study is to determine if dronabinol decreases the symptoms of marijuana
addiction and withdrawal.
A Phase I/II Study to Evaluate Single Agent and Combination Therapy With Megestrol Acetate and Dronabinol for the Treatment of HIV-Wasting Syndrome [Completed]
To obtain data on the safety of administering megestrol acetate and dronabinol as single
agents or in combination to patients with human immunodeficiency virus (HIV)-wasting
syndrome. To obtain preliminary data on the efficacy of single agent and combination therapy
with megestrol acetate and dronabinol with regard to weight gain, appetite increase and
quality of life in this patient population. To obtain steady-state pharmacokinetics data when
megestrol acetate and dronabinol are administered as single agents and in combination.
HIV-wasting syndrome, which is characterized by severely debilitating anorexia and weight
loss, is of particular concern because it can exacerbate the primary illness and is
associated with a poor prognosis. Attempts at maintaining body mass through the use of
megestrol acetate and dronabinol, two anti-cachectic drugs, may prolong survival.
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