Pathological Gambling — Investigation of Naltrexone for Pathological Gambling
Citation(s)
Dannon PN, Lowengrub K, Gonopolski Y, Musin E, Kotler M Pathological gambling: a review of phenomenological models and treatment modalities for an underrecognized psychiatric disorder. Prim Care Companion J Clin Psychiatry. 2006;8(6):334-9.
Grant JE, Kim SW, Hartman BK A double-blind, placebo-controlled study of the opiate antagonist naltrexone in the treatment of pathological gambling urges. J Clin Psychiatry. 2008 May;69(5):783-9.
Kim SW, Grant JE, Adson DE, Shin YC Double-blind naltrexone and placebo comparison study in the treatment of pathological gambling. Biol Psychiatry. 2001 Jun 1;49(11):914-21.
Kim SW, Grant JE An open naltrexone treatment study in pathological gambling disorder. Int Clin Psychopharmacol. 2001 Sep;16(5):285-9.
Melville KM, Casey LM, Kavanagh DJ Psychological treatment dropout among pathological gamblers. Clin Psychol Rev. 2007 Dec;27(8):944-58. Epub 2007 Mar 2. Review.
Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.