Track topics on Twitter Track topics that are important to you
Insomnia and other sleep abnormalities are common, persistent, and associated with relapse in alcohol-dependent patients. The overall, long-term objectives of the proposed research are to investigate the neurophysiologic mechanisms of sleep disturbance that are associated with relapse in patients with alcohol dependence, and to target those mechanisms with medication in order to reduce relapse risk.
The specific research aims are:
1. To investigate three potential mechanisms of sleep disturbance in alcoholic patients: impaired sleep drive, impaired circadian regulation of alertness, and brain hyperactivation;
2. To investigate short-term effects of medication on sleep and its regulatory mechanisms in alcoholics;
3. To investigate the short-term clinical course of alcoholism as a function of baseline sleep parameters.
In Study Phases I & II (Screening & Baseline: 10+ days), subjects are assessed to diagnose alcohol dependence, determine baseline values for drinking and sleeping, and rule out confounding sleep-impairing causes.
Phase III (Medication: 10 days), is a randomized, double-blind parallel design comparison of gabapentin vs. placebo on mechanisms of sleep. It is not a therapeutic or clinical trial. Phases II & III each have 7 days of monitoring sleep and activity, followed by 3 nights in the sleep laboratory to assess all-night EEG activity and Dim-Light Melatonin Onset (DLMO), a measure of circadian rhythm.
Phase IV is a 2-day medication taper and Phase V (Follow-up) consists of one visit after 12 weeks to assess course of drinking.
In summary, sleep disturbance in alcoholic patients increases their risk of relapse. This study proposes to investigate the mechanisms causing sleep disturbance in alcoholics and to determine if those mechanisms predict return to drinking after 12 weeks.
Relevance: Alcoholism is a devastating chronic disorder that in any one year affects 10% of adults, costs over $185 billion, and causes more than 100,000 deaths in the U.S. Despite treatment, most alcoholic patients achieve only short-term abstinence. Medically-based treatment improvements are needed that target neurophysiologic mechanisms of relapse. Overall public health will be improved by developing science-based treatments that can augment existing, but only partially effective, treatment approaches.
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)
Gabapentin or placebo dispensed to subject., Gabapentin or placebo dispensed to subject.
University of Michigan Health System
University of Michigan
Published on BioPortfolio: 2014-07-23T21:11:47-0400
This study evaluates the efficacy and safety of gabapentin relative to tramadol for the treatment of chronic, neuropathic or mixed pain in the paediatric population. Children from 3 months...
The study is to observe the effects of gabapentin premedication on postoperative pain,vomiting and nausea in patients undergoing neurosurgery. 100 neurosurgical patients are randomized int...
The evidence regarding effects of pain modulator like gabapentin on postoperative pain after sleeve gastrctomy is sparse. Gabapentin has anti-hyperalgesic and postoperative opioid-sparing ...
Gabapentin is an antiepileptic drug. Its antiemetic effect is demonstrated after laparoscopic surgery, but it is not yet known whether gabapentin is effective in preventing chemotherapy in...
This is a study to evaluate the efficacy of the medication gabapentin in treating persons with an alcohol problem.
Gabapentin is an anticonvulsant drug widely prescribed for various ailments, including orofacial pain. It was once thought to have no potential for abuse; however, the last decade has seen a dramatic ...
Prescription opioid use is highly associated with risk of opioid-related death, with 1 of every 550 chronic opioid users dying within approximately 2.5 years of their first opioid prescription. Althou...
Cough is a common problem among cancer patients, especially lung cancer patients. Gabapentin has been shown to be effective in reducing cough number and severity in patients with idiopathic refractory...
Pain management after spinal surgery has been studied for years. Gabapentin is a third-generation antiepileptic drug that selectively affects the nociceptive process and has been used for pain relief ...
Substitution by generic drugs is allowed when bioequivalence to the originator drug has been established. However, it is known that similarity in exposure may not be achieved at every occasion for all...
Misunderstanding among individuals, frequently research subjects, of scientific methods such as randomization and placebo controls.
Books used in the study of a subject that contain a systematic presentation of the principles and vocabulary of a subject.
Terms or expressions which provide the major means of access by subject to the bibliographic unit.
An effect usually, but not necessarily, beneficial that is attributable to an expectation that the regimen will have an effect, i.e., the effect is due to the power of suggestion.
A personality assessment technique in which the subject or observer indicates the degree to which a standardized set of descriptive statements actually describes the subject. The term reflects "sorting" procedures occasionally used with this technique.
Sleep disorders disrupt sleep during the night, or cause sleepiness during the day, caused by physiological or psychological factors. The common ones include snoring and sleep apnea, insomnia, parasomnias, sleep paralysis, restless legs syndrome, circa...
Pharmacy is the science and technique of preparing as well as dispensing drugs and medicines. It is a health profession that links health sciences with chemical sciences and aims to ensure the safe and effective use of pharmaceutical drugs. The scope of...