Opioid-Related Disorders Clinical Trial
Official title:
Buprenorphine for Treatment of Opioid Dependence in Primary Care
The purpose of this treatment research study is to assess the effectiveness of buprenorphine maintenance treatment for opioid dependence delivered in a primary care clinic setting. This study will determine whether buprenorphine treatment in primary care is effective in reducing cravings, reducing illicit opioid use, reducing addiction severity, and retaining patients in primary care treatment for opioid dependence.
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.
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