H.  Is The Patient Opioid Dependent, Appropriate For, And Willing To Engage In Opioid Agonist Therapy (OAT)?

 

OBJECTIVE

 

Assure careful consideration of OAT as the first line treatment for opioid dependence.

For DoD active duty, OAT is generally not a treatment option.

 

ANNOTATION

 

Opioid dependence is a cluster of cognitive, behavioral, and physiological symptoms characterized by repeated self-administration and usually results in opiate tolerance, withdrawal symptoms, and compulsive drug taking, despite negative consequences.  While new Federal regulatory language uses the term “opiate addiction,” the diagnostic term “opioid dependence” will be used here for consistency with the rest of the guideline.  Dependence may occur with or without the physiological symptoms of tolerance and withdrawal.  OAT for opioid dependence consists of administering an opioid agonist medication, such as methadone or levo-alpha-acetylmethadol (LAAM), in combination with a comprehensive range of medical, counseling, and rehabilitative services.  By administering an opioid to prevent withdrawal, reduce craving, and reduce the effects of illicit opioids, the opioid dependent patient is able to focus more readily on recovery activities.  When compared to detoxification attempts, OAT is more successful in achieving the long-term goal of reducing opioid use and associated negative medical, legal, and social consequences.

 

Provide access to OAT for all opioid dependent patients, under appropriate medical supervision and with concurrent addiction-focused psychosocial treatment (See Module R: Assessment and Management in Specialty Care).

 

  1. Consider methadone maintenance for its documented efficacy in reducing illicit opioid use, HIV risk behavior, and drug-related criminal behavior.
  2. Consider LAAM, a long-acting, synthetic mu-agonist, a safe and effective alternative to methadone maintenance.
  3. Consider the acceptability and feasibility of regular clinic attendance.  Under Federal regulations of OAT programs, for the first 90 days of treatment the patient should attend clinic at least six days per week for methadone or three times per week for LAAM.

Refer to Table 2 for indications, contraindications, side effects, and drug interactions of methadone and LAAM.

 

Table 2.  Agonist Therapy for Opioid Dependence

 

Opioid Agonists:   Methadone and LAAM

Indications

·     Opioid dependence > 1 year

·     Two or more unsuccessful opioid detoxification episodes within a 12 month period

·     Relapse to opioid dependence within 2 years from OAT discharge

Contraindications

·     Allergy to agent

·     Concurrent enrollment in another OAT

·     Significant liver failure

·     Use of opioid antagonists (e.g., naloxone, nalmefene, or naltrexone)

Side Effects

·     Common: constipation

·     Less common: sexual dysfunction

Drug Interactions

·     Drugs that reduce serum methadone level: phenytoin, carbamazapine, rifampin, barbiturate sedative-hypnotics, some anti-virals, ascorbic acid, and chronic ethanol use

·     Drugs that increase serum methadone level: cimetidine, ketoconazole, fluconazole, amitriptyline, diazepam, and fluvoxamine maleate

 

 

DISCUSSION

 

OAT is inaccurately considered by some providers to be a treatment of last recourse; however, evidence consistently shows that patients have better outcomes when maintained with an agonist than a placebo (Newman and Whitehall, 1979; Strain et al., 1993a; Strain et al., 1993b) or than when provided long-term detoxification (Sees et al., 2000).  Discharge from OAT programs is generally followed by relapse and other adverse outcomes (Gerstein et al., 1994; Magura & Rosenblum, in press).  Unless there are legal or other extenuating circumstances, (such as active duty in DoD), OAT should be considered for any patient with a diagnosis of opioid addiction.  For patients who previously relapsed, re-treatment should be a consideration.  As part of the decision process, it is important to determine if appropriate agonist dosing was utilized and whether there were psychosocial barriers that could be better addressed upon re-attempting OAT.

 

Effective May 2001, the Substance Abuse and Mental Health Services Administration (SAMHSA), through its Center for Substance Abuse Treatment (CSAT), will regulate OAT programs as codified in 42 CFR Part 8 “Opioid Drugs in Maintenance and Detoxification of Opiate Addiction” (http://www.samhsa.gov/news/click5_frame.html).  The new criteria for admission to OAT programs require that patients have been addicted to an opioid drug for at least 1 year prior to admission and that they provide voluntary informed consent to maintenance treatment.  If considered clinically appropriate, the regulations provide exceptions to the requirement of a 1 year history of addiction for patients released from penal institutions within the prior 6 months, for pregnant patients, and for patients discharged from maintenance treatment within the prior 2 years.

 

The OAT program can provide short- or long-term detoxification and other services to patients not eligible for maintenance treatment; however, patients with 2 or more unsuccessful detoxification episodes within a 12-month period must be assessed by the OAT physician for other forms of treatment.

 

The Drug Addiction Treatment Act of 2000 makes opioids available to the office practitioner, in DEA Schedules III, IV, and V, with an FDA-approved indication for the treatment of opioid dependence.  At the time this guideline is written, no medications are approved for such use other than methadone and LAAM, both of which are DEA Schedule II medications.  However, it is anticipated that the FDA will approve in 2001 a partial mu-agonist, buprenorphine, for the treatment of opioid dependence; it is further anticipated that buprenorphine and/or a combination of buprenorphine/naloxone will fall within the guidelines of the Drug Addiction Treatment Act of 2000.  Clinical practice guidelines and education material on the use of buprenorphine and buprenorphine/naloxone in office-based practice for the treatment of opioid dependence are being developed.  More information is available at http://www:samhsa.gov.

 

EVIDENCE TABLE

 

 

Recommendations

Sources of Evidence

QE

 

R

1

Consider OAT the first line treatment for opioid dependence.

National Consensus Development Panel on Effective Medical Treatment of Opiate Addiction, 1998

Sees et al., 2000

I

 

A

2

Methadone maintenance, at adequate doses, is efficacious in reducing opioid use.

Strain et al., 1993a

Strain et al., 1993b

Marsch, 1998

Johnson, 2000

I

 

A

3

LAAM maintenance, at adequate doses, is an effective alternative to methadone maintenance.

Eissenberg et al., 1997

Glanz et al., 1997

I

 

A

QE = Quality of Evidence; R = Recommendation (See Introduction)