Study of Buprenorphine Maintenance Treatment for Opioid Dependence in Primary Care (NCT00471042) | Clinical Trial Compass
CompletedNot Applicable
Study of Buprenorphine Maintenance Treatment for Opioid Dependence in Primary Care
United States30 participantsStarted 2006-06
Plain-language summary
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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.