BEHAVIORAL FAMILY COUNSELING AND NALTREXONE FOR MALE OPIOID-DEPENDENT PATIENTS

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 • Age 32.4 (6.2) Years • Education 13.2 (2.1) Years • Race/Ethnicity 61% Minority • Opioid Use 6.6 (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-UpASI 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