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Raymond F. Anton, MD for The COMBINE Study Research Group

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1 Raymond F. Anton, MD for The COMBINE Study Research Group
Combined Pharmacotherapies and Behavioral Interventions for Alcohol Dependence (The COMBINE Study): A Randomized Controlled Trial Overview of Within Treatment Primary Outcomes Raymond F. Anton, MD for The COMBINE Study Research Group JAMA Vol. 295, , 2006 (May 3rd)

2 Treatment Group Combinations (1383 Randomized participants)

3 Primary Outcome Measures
Percent Days Abstinent during treatment period Time to relapse (number relapsed) to heavy drinking Males: 5 drinks / day; Females: 4 drinks / day Secondary Outcome Measures Global Clinical Outcome Craving – OCDS Other Drinking Measures Biological Markers (%CDT, GGT)

4 Participant Adherence / Retention
*MM vs. CBI, p=0.05

5 Completion of Drinking Assessments

6 Reasons for Treatment Withdrawal

7 Adverse Events (SAFTEE Interview)
* Nominal p-values for placebo vs. active drug comparisons: *p<0.05, **p<0.01, ***p<0.001

8 Results

9 PDA during Treatment (16 weeks)

10 PDA during Treatment (continued)

11 PDA Effect Size at Week 16

12 Relapse to Heavy Drinking During Treatment (16 weeks)

13 Relapse to Heavy Drinking by Week 16 (continued)

14 Relapse to Heavy Drinking, Naltrexone Effect

15 Relapse to Heavy Drinking, Naltrexone x CBI Interaction

16 Relapse to Heavy Drinking at Week 16

17 Relapse to Drinking (first drink), Acamprosate Effect

18 Acamprosate Secondary Outcomes Effect Size

19 Naltrexone Secondary Outcomes Effect Size

20 CBI Secondary Outcomes Effect Size

21 Secondary Outcomes Naltrexone x CBI

22 Composite Clinical Outcome* during Last 8 Weeks of Treatment
Naltrexone by CBI interaction, p=0.02 *No more than 2 days heavy drinking over eight weeks and no more than 11 (women) or 14 (men) drinks per week and no alcohol problems

23 % Good Clinical Outcomes (16w)
CBI X Naltrexone interaction: p = .02

24 Odds Ratios for Good Clinical Outcome Naltrexone Comparisons

25 Odds Ratios for Good Clinical Outcome
Acamprosate Comparisons

26 Summary There was marked improvement in all groups
Acamprosate showed no greater efficacy than placebo In the context of medical management both naltrexone and CBI were more efficacious than placebo There was no increase in efficacy by combining acamprosate with naltrexone or by adding either medication to CBI

27 Implications Alcohol dependent patients may benefit from being treated by a health care professional who adopts medical management and utilizes either naltrexone and/or refers to a specialized alcohol counselor using CBI-like techniques. This broadens options for treatment for those not previously being treated.

28 Limitations Select sample of outpatient alcoholics – generalizability to others needs to be done with caution Doses used were higher than those in the NDA for FDA approval MM delivered in the context of substance abuse facilities not in “primary care settings” Potential of assessment effects adding to overall response Only a few subjects were in need of medical alcohol detoxification - ? Implications for acamprosate Therapists were trained and monitored - ? Implications for CBI in clinical settings

29 Future Data Evaluating predictors of treatment response including genetic markers of response Evaluation of the Economic Impact of the Treatments over an extended period of time-Cost Effectiveness Study Evaluating what components of the therapies accounted for greater response including compliance and adherence

30 Acknowledgements Data presented in this presentation were collected as part of the multisite COMBINE trial sponsored by: National Institute on Alcohol Abuse and Alcoholism Acamprosate, naltrexone and their matching placebos were kindly donated by Lipha Pharmaceuticals. Data and Safety Monitoring was conducted by: R Hingson ScD C Meinert PhD R Kadden PhD R Saitz MD MPH M McCaul PhD Gerard Connors PhD A full listing of the staff of the COMBINE Study can be found at

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