OBJECTIVE: The purpose of this study was to examine the nature of the effect of placebo medication plus accompanying medical management in the treatment of alcohol dependence. METHOD: The National Institute on Alcohol Abuse and Alcoholism COMBINE (Combining Medications and Behavioral Interventions) study, a randomized controlled double-blind trial of 1,383 alcohol-dependent patients, compared combinations ofmedications (acamprosate [Campral] and naltrexone [ReVia]) and behavioral therapy (medical management and specialist-delivered behavioral therapy) for alcohol dependence. This report focuses on a subset of that study population (n = 466) receiving (1) specialized behavioral therapy alone (without pills), (2) specialized behavioral therapy + placebo medication + medical management, or (3) placebo + medical management. RESULTS: During 16 weeks of treatment, participants receiving behavioral therapy alone had a lower percentage of days abstinent (66.6%) than did the participants receiving placebo and medical management (73.1%) or those receiving specialized behavioral therapy + placebo + medical management (79.4%). The group receiving behavioral therapy alone relapsed to heavy drinking more often (79.0%) than those receiving behavioral therapy + placebo + medical management (71.2%). This report focuses on potential explanations for this finding. The two groups of participants receiving placebo + medical management were more likely to attend Alcoholics Anonymous meetings during treatment (32.7% and 32.0% vs 20.4%) and were less likely to withdraw from treatment (14.1% and 22.9% vs 29.3%). CONCLUSIONS: There appeared to be a significant "placebo effect" in the COMBINE Study, consisting of pill taking and seeing a health care professional. Contributing factors to the placebo response may have included pill taking itself, the benefits of meeting with a medical professional, repeated advice to attend Alcoholics Anonymous, and optimism about a medication effect.
RCT Entities:
OBJECTIVE: The purpose of this study was to examine the nature of the effect of placebo medication plus accompanying medical management in the treatment of alcohol dependence. METHOD: The National Institute on Alcohol Abuse and Alcoholism COMBINE (Combining Medications and Behavioral Interventions) study, a randomized controlled double-blind trial of 1,383 alcohol-dependent patients, compared combinations of medications (acamprosate [Campral] and naltrexone [ReVia]) and behavioral therapy (medical management and specialist-delivered behavioral therapy) for alcohol dependence. This report focuses on a subset of that study population (n = 466) receiving (1) specialized behavioral therapy alone (without pills), (2) specialized behavioral therapy + placebo medication + medical management, or (3) placebo + medical management. RESULTS: During 16 weeks of treatment, participants receiving behavioral therapy alone had a lower percentage of days abstinent (66.6%) than did the participants receiving placebo and medical management (73.1%) or those receiving specialized behavioral therapy + placebo + medical management (79.4%). The group receiving behavioral therapy alone relapsed to heavy drinking more often (79.0%) than those receiving behavioral therapy + placebo + medical management (71.2%). This report focuses on potential explanations for this finding. The two groups of participants receiving placebo + medical management were more likely to attend Alcoholics Anonymous meetings during treatment (32.7% and 32.0% vs 20.4%) and were less likely to withdraw from treatment (14.1% and 22.9% vs 29.3%). CONCLUSIONS: There appeared to be a significant "placebo effect" in the COMBINE Study, consisting of pill taking and seeing a health care professional. Contributing factors to the placebo response may have included pill taking itself, the benefits of meeting with a medical professional, repeated advice to attend Alcoholics Anonymous, and optimism about a medication effect.
Authors: Keith Humphreys; Stephen Wing; Dennis McCarty; John Chappel; Lewi Gallant; Beverly Haberle; A Thomas Horvath; Lee Ann Kaskutas; Thomas Kirk; Daniel Kivlahan; Alexandre Laudet; Barbara S McCrady; A Thomas McLellan; Jon Morgenstern; Mike Townsend; Roger Weiss Journal: J Subst Abuse Treat Date: 2004-04
Authors: Raye Z Litten; I-Jen P Castle; Daniel Falk; Megan Ryan; Joanne Fertig; Chiung M Chen; Hsiao-ye Yi Journal: Alcohol Clin Exp Res Date: 2013-07-24 Impact factor: 3.455
Authors: Roger D Weiss; Margaret L Griffin; David E Marcovitz; Blake T Hilton; Garrett M Fitzmaurice; R Kathryn McHugh; Kathleen M Carroll Journal: J Clin Psychiatry Date: 2019-03-26 Impact factor: 4.384
Authors: Susan E Collins; Andrew J Saxon; Mark H Duncan; Brian F Smart; Joseph O Merrill; Daniel K Malone; T Ron Jackson; Seema L Clifasefi; Jutta Joesch; Richard K Ries Journal: Contemp Clin Trials Date: 2014-05-17 Impact factor: 2.226
Authors: Katie Witkiewitz; John W Finney; Alex H S Harris; Daniel R Kivlahan; Henry R Kranzler Journal: Alcohol Clin Exp Res Date: 2015-08-06 Impact factor: 3.455