# Presentation: 802061

## BEHAVIORAL FAMILY COUNSELING AND NALTREXONE FOR MALE OPIOID-DEPENDENT PATIENTS

- William Fals-Stewart, Ph.D.
*Research Institute on Addictions*

## 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

## 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*

## 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*

## Enhancing Naltrexone Compliance: Two Methods

- Voucher-Based Reinforcement Methods
- Family/Significant Other (SO) Approaches

## 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

## 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

## 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

## 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?

## Participants

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

## 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%*

## 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)

## 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*

## 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

## Results: Primary Outcomes

- Treatment Response Indicators
*Naltrexone Compliance*
*Substance Use*
- Posttreatment Outcomes
*Substance Use*
*Psychosocial Functioning*

## Treatment Response Indicators

*Effects During Primary Treatment*

## Days of Naltrexone Ingestion

## Percentage of Opioid-Free Urines During Treatment

## Opioid Survival: During Treatment

**BFC**

**IBT**

## Posttreatment Outcomes

*12-Month Follow-Up*

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

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

**BFC**

**IBT**

## 12-Month Follow-UpASI Composite Scores

## 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*

## Summary

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

## Limitations

- Engagement of Participants
*Participant Recruitment Difficult*
*Reluctance to Take Naltrexone*
- Requires Positive Family Participation
*Often Difficult*

## Ongoing Research

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

## Support

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

## 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*