REDUCING SUBSTANCE ABUSE: THE EMERGING ROLE OF PRIMARY CARE

1

Office-Based Treatment of Substance Use Disorders
Patrick G. OConnor, MDProfessor and
ChiefSection of General Internal MedicineYale
University School of Medicine
The International AIDS SocietyUSA
2
OVERVIEW

• Epidemiology of Alcohol and Drug Abuse in General
  Medical and HIV Office-based Settings
• New Models that Expand the Role of Primary Care
  and HIV Office-based Providers in Treating
  Substance Use Disorders
• Brief interventions for at risk and problem
  drinking
• Pharmacotherapy for alcohol dependence
• Office-based treatment of opioid dependence
• Summary The Role of Generalist and HIV
  Clinicians in Office-based Treatment of Substance
  Use Disorders

3
At Risk and Problem DrinkersBrief Interventions

• 1. Brief 2 - 20 minutes, once or
  repeatedly.
• 2. Designed specifically for outpatient
  settings.
• Employ counseling strategies used by generalists.
• Multiple randomized trials have demonstrated the
  effectiveness of BIs.

4
BMJ, September 6, 2003 Vol. 327
5
Naltrexone

• 1. Mechanism of Action opioid receptor
  blockade
• 2. Effects decreased craving and alcohol
  consumption
• 3. Dose 50 mg tablet, once a day (FDA
  approved 1994)
• 4. Side Effects nausea (10), headache
• 5. Contraindications opioid dep., severe liver
  disease
• 6. New Depot Preparation 340 mg
  intramuscularly every 4 weeks (FDA approved
  2006)

6
Addiction, July 2004 Vol. 99, No. 7
7
Additional Questions About Naltrexone

• 1. Is naltrexone effective when used in
• a primary care model of therapy?
• 2. Is continued naltrexone (gt 12 wks)
• efficacious in those who respond
• to short term therapy?

8
Naltrexone Initial and Maintenance Treatment
STUDY 1 Initial Naltrexone Treatment Randomized
(n 197) 10 weeks
Received CBT NTX (n 97)
Received PCM NTX (n 93)
STUDY 2. CBT Naltrexone Maintenance Responders
randomized (n 60) 24 weeks
STUDY 3. PCM Naltrexone Maintenance Responders
randomized (n 53) 24 weeks
Received CBT NX (n 30)
Received CBT PLA (n 30)
Received PCM NX (n 26)
Received PCM PLA (n 27)
9
Study 1 Initial Naltrexone Treatment

• CBT
  PCM p
• (n97) (n93)
• Primary Outcomes
• Responder (n, ) 77 (79.4) 74 (79.6) ns
• Percentage of days abstinent 79.9 31.4 77.9
  30.9 ns
• Secondary Outcomes
• Drinks per drinking day 3.3 5.6 3.3 4.7 ns
• No relapse to heavy drinking 60 (61.9) 52
  (55.9) ns
• Continuous Abstinence (n, ) 43 (44.3) 31
  (33.3) ns
• GGT end point change
• from baseline (mean SD) -43.1 75.3 -37.9
  65.7 ns
• OCDS total score
• Therapy (mean SD) 8.0 5.4 8.2
  5.8 ns

10
Opioid DependenceTreatment Options

• Drug Free vs pharmacologically-based
• Counseling strategies pharmacotherapy
• Detoxification treatment poor long term outcomes
• Clonidine/Lofexidine
• Methadone/Buprenorphine
• Rapid and Ultrarapid Detoxification
• Maintenance treatments highly effective but
  historically difficult to access
• Naltrexone
• Methadone
• Buprenorphine
• Office-based treatment with buprenorphine

11
Rationale Office-basedOpioid Treatment

• Increase access to treatment approximately 80
  of opioid dependent individuals not in treatment
• Improve coordination of general medical,
  psychiatric, and substance abuse care
• Treat opioid dependence like other chronic
  diseases
• Limit contact with patients still actively using
  drugs

12
Drug Addiction Treatment Act 2000 (DATA 2000)

• Amendment to the U. S. Federal 1970 CSA.
• The practitioner is licensed and qualifying
  based on either
• certification (Addiction Psychiatry, ASAM, AOA),
  or
• completed eight hours of training
• The drug must be Schedule III-V and NOT a
  Schedule II (i.e.
• methadone) - DATA 2000 - an act without a
  drug.
• Practitioner must be able to refer patients for
  counseling.
• Initially, practitioners (group) limited to 30
  patients.
• ONDCPRA 2006 limit increased to 100 patients.

13
Buprenorphine Pharmacology

• Partial mu-opioid receptor agonist
• Blocks effects of injected full agonists
• Ceiling effect on respiratory and CNS depression
  - safer than a pure agonist (re overdose)
• Less dependence and withdrawal
• Good bioavailability after sublingual dose
• Long acting daily to 3x/week dosing

14
Buprenophine/Naloxone

• Sublingual buprenorphine good bioavailability
• Sublingual naloxone poor bioavailability
• Thus, if used sublingually predominately
  buprenorphine effect
• If used intravenously predominately naloxone
  effect (ie. acute opiate withdrawal in physically
  dependent patients)
• Designed to maximize effectiveness and safety
  while minimizing diversion to IV use

15
Buprenophine/Naloxone

• FDA approved 2002 Schedule III, DATA 2000
  finally has a drug to fit the new law!
• Dose formulations 2 mg or 8 mg buprenorphine
  naloxone
• Induction a few to several days
• Typical maintenance dose 16-24 mg/day (often
  lower)

16
BuprenorphineCounseling Component

• Counseling is essential, patient centered
• Intensity needed varies among patients
• Office based team members may include MD, APRN,
  PA, RN, counseling staff, care coordinators,
  others
• Additional assistance from outside specialists
  (eg Psychiatry) or programs (eg NA,
  counselling centers) often helpful.
• Triage to specialty care may be warranted in
  treatment failures.

17
http//buprenorphine.samhsa.gov/
18
HRSA SPNSBuprenorphine in HIV Care Settings

• 10 Demonstration sites (coast to coast)
• 1 Evaluation and Support Center (Yale)
• 5 years
• Examining models of buprenorphine treatment for
  individuals with HIV disease
• To date, 270 participants, and growing

19
Models of Integration

• On-site addiction specialist
• Psychiatrist
• Other physician certified in Addiction Medicine
• HIV physician Buprenorphine certified
• Team management MD, PA, NP provider coordinate
  care with case management

20
Roles for Office-based Providers

• Screen identify substance abuse in their
  patients.
• Assess identify and manage substance
  abuse-related risks complications.
• Treat provide substance abuse treatment directly
  to patients brief intervention and
  pharmacotherapy.
• Refer patients to treatment programs when
  indicated.
• Learn continually educate themselves on the
  management of substance use disorders and
  related co-morbidities.