Study of Buprenorphine Maintenance Treatment for Opioid Dependence in Primary Care

Buprenorphine maintenance treatment of opioid dependence in primary care may expand treatment
access. Buprenorphine is a partial mu-opioid agonist approved for treatment of opioid
dependence (dependence on heroin, prescription opioid pain medication, or methadone), which
can be prescribed in primary care by authorized physicians. The purpose of this study is to
assess the effectiveness of buprenorphine maintenance treatment in a primary care setting.
Outcome measures include illicit opioid use during treatment, addiction severity scores from
the Addiction Severity Index (ASI), patient craving ratings on a 100mm visual analog scale
(VAS), and patient retention in treatment.

This is a 6-month, prospective cohort study of adults aged 18-65 who are seeking
buprenorphine maintenance treatment for opioid dependence. This study is observational, not
experimental, and patients will be treated in a naturalistic condition according to their
individual treatment needs. Clinic visits will occur weekly for the first 4 weeks (Induction
and Stabilization Phases), and monthly for the remaining 20 weeks (Maintenance Phase), at
which time up to a month of medication may be prescribed. Participation in ancillary
psychosocial treatment is recommended but not required. Urine toxicology and craving ratings
will be collected at each visit. Additionally, research visits will occur monthly to collect
data assessing addiction severity, risk factors, general health, and psychiatric symptoms.

Inclusion Criteria:

- DSM-IV criteria for current opioid dependence

- Must be seeking treatment

- Must describe opioid medication or heroin as primary drug of abuse

- Must be financially able to receive treatment at the primary care clinic site and to
receive medication (e.g., Medicaid)

- Able to give informed consent and comply with study procedures

Exclusion Criteria:

- Axis I psychiatric disorder(s) as defined by DSM-IV-TR that are unstable or would be
disrupted by study participation

- Individuals at significant risk for suicide based on current mental state

- DSM-IV dependence with physiologic dependence other than opioid and nicotine

- Women must not be pregnant or lactating, and must agree to use a proven effective
method of contraception and not become pregnant during the study

- Unstable physical disorder that might make participation hazardous

- Known allergy, sensitivity or adverse reaction to buprenorphine

- Current buprenorphine maintenance

- Inability to read or understand the self-report assessment forms unaided