HYCOMINE SUMMARY
HYCOMINE Compound tablets contain hydrocodone (dihydrocodeinone) bitartrate, a semi-synthetic centrally-acting opioid antitussive; chlorpheniramine maleate, an antihistamine; phenylephrine hydrochloride, a sympathomimetic amine decongestant; acetaminophen, an analgesic/antipyretic; and caffeine, a centrally-acting stimulant, for oral administration.
HYCOMINE Compound is indicated for the symptomatic relief of cough, nasal congestion, and discomfort associated with upper respiratory tract infections.
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NEWS HIGHLIGHTS
Clinical Trials Related to Hycomine (Hydrocodone / Chlorpheniramine / Phenylephrine / Acetaminophen / Caffeine)
Assessment and Treatment of Caffeine Dependence [Recruiting]
Recent research has established that some individuals report that they are unable to cease
caffeine use, despite feeling that caffeine is posing a health risk or causing significant
impairment in their daily activities. Despite the high rates of unsuccessful efforts to
cease or control caffeine use in the population, there has been little research on the
parameters of successful caffeine reduction and no research on caffeine cessation.
The goals of the study are as follows:
1. evaluate the applicability of DSM-IV dependence criteria for self-reported problematic
caffeine use.
2. evaluate characteristics (e. g, co-morbid psychopathology) of individuals who report
that they have had difficulty quitting caffeine use on their own and who are seeking
treatment for caffeine use.
3. test the efficacy of a caffeine reduction treatment administered to individuals who
would like to quit/reduce caffeine use, but have found it difficult to do so in the
past.
The Impact of Caffeine on Brachial Endothelial Function in Healthy Subjects and in Patients With Ischemic Heart Disease [Recruiting]
Prior work (Chris, M. et al, Clinical Science 2005; 109, 55-60) has demonstrated that
drinking a cup of coffee (80-100 mg of caffeine) an hour before endothelium-dependent FMD
(flow-mediated dilatation) of the brachial artery, effects endothelial function in healthy
adults subjects.
This effect might be attributed to caffeine, given that decaffeinated coffee (<2 mg of
caffeine) was not associated with any change in endothelial performance.
In the current study we intend to further examine the impact of caffeine on brachial
endothelial function among healthy subjects & in patients with proven ischemic heart
disease.
Caffeine for Excessive Daytime Somnolence in Parkinson's Disease [Recruiting]
Many patients with Parkinson's disease (PD) have sleep problems, including excessive
sleepiness during the day. This is probably due to degeneration of sleep-regulating areas
in the brain. At present, the only treatment for sleepiness in PD is modafinil, which is
expensive and only partially effective. There is another potential treatment for sleepiness
that is used worldwide, is inexpensive, well tolerated and safe - namely, caffeine. There
have also been suggestions that caffeine may slow the progression of degeneration in PD,
since coffee non-drinkers are at higher risk of developing PD. PD patients, even with
severe sleepiness often do not use caffeine. It is unclear whether this is because their PD
makes their sleepiness unresponsive to caffeine, because they cannot tolerate it, or whether
this reflects their lifelong habit of non-use. This proposal outlines a trial in which
patients with excessive sleepiness will be given caffeine or placebo (no therapy) in a
blinded fashion. In this way, the effect of caffeine on sleepiness and motor symptoms can
be directly analyzed. In addition, these findings can be used to test the tolerability of
caffeine, to help plan a larger-scale study testing whether caffeine can slow the
progression of PD
Experimental Studies of the Effects of Caffeine on Glucose Regulation [Completed]
This project contains experimental studies of the effects of the drug caffeine on glucose
regulation in adults who have Type 2 diabetes. In our experiments, we are testing the
hypothesis that moderate amounts of caffeine exaggerate the abnormal increases in glucose and
insulin observed after meals in patients with type 2 diabetes. On separate study days
subjects receive standard meals after taking capsules containing either caffeine or an
inactive placebo. We measure levels of glucose, insulin, and other chemicals in blood
samples drawn over the next 3 hours. In a separate study, we use continuous glucose
monitoring to measure glucose levels during everyday activities on days when subjects receive
caffeine or placebo.
These studies do not involve clinical treatment or disease management. However, we hope to
learn whether a very popular drug impairs the clinical management of a common disease.
Effects of Low Doses of Caffeine on Mood, Physiology and Mental Function [Completed]
It is often assumed that levels of caffeine found in ‘decaffeinated’ beverages are below any
psychopharmacological threshold. However, recent findings indicate that caffeine doses as low
as 9 mg may be psychoactive. The effects of caffeine have also been shown up to 6 hours
post-administration. The study aimed to establish the lowest active dose of caffeine, and to
ascertain the duration of any effects.
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