Extended vs Short-term Buprenorphine-Naloxone for Treatment of Opioid-Addicted Youth A Randomized Trial

Question 1

What is Buprenorphine

Answer 1

• Schedule III opioid partial agonist with a greater margin of safety than full agonists and a less intensive withdrawal
• Approved for use with 16+ years old
• combined wtih naloxone in 4:1 ratio to reduce abuse if crushed & injected
• studied mainly in adults addicted 5-10 years

Question 2

Who participated

Answer 2

• individuals aged 14-21
• met DSM-IV criteria for opiois dependence with physiologic features
• seeking out-patient treatment
• Excluded: psychiatric or medical conditions likely to make participation difficult or unsafe / alcohol or sedative abuse + tons of others (not imp)

Question 3

Randomnized

Answer 3

• rendomnized to 14 day outpatient detox or 12 weeks of treatment with buprenorphine-naloxone
• 78 patients to detox
• 74 patients to receive 12 weeks of buprenorphine-naloxone

Question 4

Drug Counseling

Answer 4

• 1 individual and 1 group session per week, more if needed
• counseling
  
  • encouraged making positive relationships
  • ceasing drug use
  • taking meds as prescribed
  • tolerating stressful events without drugs
  • keeping appointments
  • teaching ways to avoid drug use situations
  • addiction education
  • positive feedback for achieving goals
  • referrals for treatment for associated conditions
  • self-help groups

Question 5

Results

Answer 5

• of 236 patients screened, 154 were randomnized and 152 entered treatment
• most common exclusion: use of benzodiazapines and failure to return
• patients in detox group less likely to remain in the assigned treatment then those in 12 week program (16 of 78 completed vs. 52 of 74 completed)
• most common reason noncompletion: missed 2 weeks of counseling
• detox patiens more likely to report enrollment in another addiction treatment but actually patients in 12 week program attended more counseling sessions

Question 6

Post-Treatment Outcomes

Answer 6

• Detox group: higher proportions of positive urine tests results than patients in 12 week program
• no difference in rates of self-reported alcohol use
• no serious adverse events re naloxone
• 4 of 83 patients who tested negative for HepC at beggining were positive at week 12 (2 each group)
• patients 12 week prgrm:less use of opiods, cocaine, marijuana / better treatment retention, less injecting and need for additional treatment while on meds
• stopping naloxone: negative effects both groups, but earlier and more severe with detox group

Question 7

Reducing Risk of HIV

Answer 7

• Methadone or Buprenorphine maintenance reduces risk of infection with HIV and overdose death
• therefore shows a benefit of naloxone for extended periods as part of standard outpatient treatment
• clinicians should not be in a hurry to stop an effective medication simply because the patient is young and has been addicted for a short time

Question 8

Limitations to Study

Answer 8

• low follow-up rate made it difficult to estimate the number of patients who achieved recovery
• almost total absence of African American individuals (though consistent with data showing they are less addictted to opioids than young white individuals)
• lack of blinding of evaluators BUT assessments were objective (urine tests, dropout)
• number patients too small to adequately capture adverse effects and nothing assessed beyond 12 months

Question 9

Clinical Implications

Answer 9

• would improve outcomes if this treatmen were available in primary care, family practice and adolescent programs
• other effective meds or longer and more intensive psychosocial treatments may have similarly positive results