An observational study in Heroin Dependence, Opioid-Related Disorders and Substance Abuse, Intravenous, sponsored by New York State Psychiatric Institute. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2019-04-23.
Sponsored by New York State Psychiatric Institute · Observational
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.
90 studies on the registry are indexed under Heroin Dependence; 1 is open to participants now.
This study's enrollment of 30 is close to the median of 30 across 17 observational studies indexed under Heroin Dependence.
Browse Heroin Dependence studies →New York State Psychiatric Institute is the lead sponsor of 435 studies on the registry; 27 are open to participants now.
Of its 51 completed or terminated interventional studies of FDA-regulated products, 45 (88%) have results posted.
Counted across the registry records on this site, refreshed daily.
Adults aged 18-65 who are seeking buprenorphine maintenance treatment for opioid dependence
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Dose is determined according to the participants' individual need.
The record gives a start of Jun 2006, a primary completion of Aug 2008 and a completion of Aug 2012. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
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