1. BEHAVIORAL FAMILY COUNSELING AND NALTREXONE FOR MALE OPIOID-DEPENDENT PATIENTS William Fals-Stewart, Ph.D. Research Institute on Addictions

2. Heroin Use: Scope of the Problem In U.S., Growing Problem –Most Common Primary Illicit Substance of Those Entering Treatment in U.S. –Cost Estimated to Be $30 Billion Annually –Only 20% of Those in Need of Treatment Actually Receive It Significant Problem Internationally

3. Pharmacological Treatment: NALTREXONE Opioid Antagonist – Blocks Subjective Reinforcing Effects of Opioid-Based Drugs Positive Outcomes for Motivated Patients –Physicians and Other Health Care Providers –Those Facing Employment Termination –Probationers and Others Facing Legal Sanctions

4. Use of Naltrexone in Community-Based Practice Despite Early Promise of Naltrexone, Not Widely Used in Community Practice Engagement and Compliance Problems –Common Delivery Approaches are Unwieldy –Standard Medication Delivery Methods Lead to Rampant Noncompliance

5. Enhancing Naltrexone Compliance: Two Methods Voucher-Based Reinforcement Methods Family/Significant Other (SO) Approaches

6. Voucher-Based Methods Recent Studies –Preston et al., 1999 –Carroll et al., 2001 Increase Compliance, Treatment Retention, and Opioid Abstinence During Period When Contingencies Were in Effect No Long-Term Follow-Up After Removal of Contingencies

7. Family-Based Approach: Behavioral Family Counseling (BFC) Spouse or Significant Other (SO) Observe Medication Taking “Medication Contract” is Established Between Patient and SO, Which is Monitored in Counseling SO Verbally (and Positively) Reinforces Patient’s Compliance

8. Behavioral Family Counseling & Medication Compliance: Previous Studies Disulfiram with Alcoholic Patients Naltrexone with Alcoholic Patients HIV Medication with Drug-Abusing Patients Lithium with Bipolar Patient

9. Aims of Present Study Would the Use of Medication Contracts Between Opioid Dependent Patients and SOs Enhance Naltrexone Compliance During Primary Treatment? What Are the Durability of Observed Effects After Primary Treatment is Completed?

10. Participants 124 Detoxified Opioid-Dependent Men Entering Outpatient Treatment Nonsubstance-Abusing SO (Intimate Partner, Parent, or Other Family Member) Willing to Participate in Treatment

11. Sociodemographics/Background Age32.4 (6.2) Years Education13.2 (2.1) Years Race/Ethnicity61% Minority Opioid Use6.6 (4.4) Years Family Member Spouses 35% Partner 13% Parent 36% Sibling 16%

12. Procedures Naltrexone Prescription to All Patients –50 mg/day Random Assignment: –Behavioral Family Counseling (BFC) –Individual-Based Treatment (IBT) Monitoring Naltrexone Compliance Within-Treatment and 12-Month Follow-Up Outcomes (Substance Use, Psychosocial)

13. Description of Treatments Behavioral Family Counseling (BFC) –Included Individual, Group, and Family Counseling during 24 weeks –“Recovery Contract” with Family Member; Included Daily Monitoring of Naltrexone Individual-Based Treatment –Included Individual and Group Counseling Only during 24 weeks –No Recovery Contract

14. Primary Measures Timeline Followback Interview –Calendar Assessment of Substance Use Frequency –Index: Percent Days Abstinent (PDA) Addiction Severity Index (ASI) –Composite Scores Urine Assay Results Pill Counts, Blister Packs

15. Results: Primary Outcomes Treatment Response Indicators –Naltrexone Compliance –Substance Use Posttreatment Outcomes –Substance Use –Psychosocial Functioning

16. Treatment Response Indicators Effects During Primary Treatment

17. Days of Naltrexone Ingestion

18. Percentage of Opioid-Free Urines During Treatment

19. Opioid Survival: During Treatment BFC IBT

20. Posttreatment Outcomes 12-Month Follow-Up

21. Percent Days Abstinent (PDA) Opioids: 12-Month Follow-Up

22. Percent Days Abstinent (PDA) All Drugs: 12-Month Follow-Up

23. BFC IBT

24. 12-Month Follow-Up ASI Composite Scores

25. Mechanisms of Action: Mediational Analyses Examined Mediational Effect of Naltrexone Compliance on Treatment Response and Outcomes #Days of Naltrexone Use Was a Significant Partial Mediator of: –Substance Use During Treatment –Substance Use After Treatment –ASI Composite Score Differences

26. Summary Participants in BFC Had Significantly Better Treatment Response and Outcome Compared to IBT Treatment Effects Were Partially Mediated by Naltrexone Compliance

27. Limitations Engagement of Participants –Participant Recruitment Difficult –Reluctance to Take Naltrexone Requires Positive Family Participation –Often Difficult

28. Ongoing Research Combination of Voucher Reinforcement and BFC BFC + Naltrexone versus BFC w/o Naltrexone Cost-Benefit and Cost-Effectiveness Studies

29. Support National Institute on Drug Abuse –R01DA012189 –R01DA014402 –R01DA014402-Supplement –R01DA015937 –R01DA016236 National Institute on Alcohol Abuse and Alcoholism –R21AA013690 Alpha Foundation

30. Contact William Fals-Stewart, Ph.D. Research Institute on Addictions 1021 Main Street Buffalo, NY 14203-1016 wstewart@ria.buffalo.edu Slides available at: www.addictionandfamilies.org