Virgil wrote:
minneapolisnick wrote:
I also fit into the group used in the studies -- no other drugs or psychiatric issues and lower Pre-Sinclair levels -- 40 to 50 units.
Hi Nick,
Would you be kind enough to point me to the page(s) in
The Cure for Alcoholism where this group is mentioned?
Many thanks.
V.
Although the book doesn't specifically describe the research subject exclusion criteria, on page 29 you'll see the "y" axis (drinks per week) for 115 successful patients peaks at an average of about 37 drinks per week, flattening out around 9 after approx. 250 days. Similar data from the first 40 patients was published in 1997.
The following is extracted from a 2001 Sinclair Study supporting TSM, titled "Targeted Use of Naltrexone Without Prior Detoxification in the Treatment of Alcohol Dependence: A Factorial Double-Blind, Placebo-Controlled Trial" (REF: The Cure For Alcoholism, Appendix A, Note 32, Page 242). Research subject exclusion criteria is described therein:
The study subjects were persons seeking outpatient treatment for alcoholism who responded to advertisements for the research study. 326 individuals were screened over the telephone, and 302 were invited for in-person screening. Of these, 137 were screened in person, and 121 gave written informed consent and were randomized for the study after one week’s run-in trial with a riboflavin-marked placebo. The inclusion criteria were 1) age 21–65 years, 2) meeting the DSM-IV criteria for alcohol dependence, 3) consumption, on average, of five or more drinks per day in the last 30 days, and 4) a stable living situation and availability of a collateral reporter.
The exclusion criteria were 1) other current drug abuse or dependence (including marijuana), 2) ever having abused opiates, 3) a current major psychiatric disorder as determined by the Structured Clinical Interview for DSM IV (SCID), 4) a serious or unstable medical condition, 5) current use of psych-otropic or anti-seizure medications or disulfiram, 6) liver function test results (alanine aminotransferase and aspartate aminotransferase) greater than 250 (IU).
Each patient signed a written informed consent, and the study was conducted according ICH’s GCP (Good Clinical Practice) and Helsinki 1964 Declaration. Ethical permission for the study was granted by the A-Clinic Foundation Ethical Committee (permission #101096).
Reasons for nonparticipation among the 302 individuals invited to be screened in person included the following: 55% chose not to participate, 1% had other psychiatric diagnoses, 2% had exclusionary medical conditions, and 2% lacked social stability. 121 patients were included: 86 males (71.1%) and 35 females (28.9%). The mean age was 45.5 years (± 7.8).