Buprenorphine Maintenance Treatment of Opioid Dependence in Primary Care: A Randomized Clinical Trial

NCT00684554 | Completed Phase 2 Results

• 2 other identifiers: #5600K23DA020000
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The study will assess the effectiveness of at-home vs. in-office induction for patients entering buprenorphine maintenance at Associates in Internal Medicine (AIM) primary care clinic.

Conditions

Opioid-Related Disorders; Heroin Dependence

Keywords

Heroin Dependence; Opioid Dependence; Primary Care; Buprenorphine

Outcome Measures

Primary Outcomes (1)

• The Primary Outcome Will Include a Comparison of the Proportion of Patients Successfully Inducted One Week After the Initial Primary Care Visit.

  The primary outcome will include a comparison of the proportion of patients successfully inducted one week after the initial primary care visit. Defined as in treatment, on Buprenorphine and withdrawal free.

  one week after initial primary care visit

Secondary Outcomes (1)

• Prolonged Withdrawal

  a) 2 days

Study Arms (2)

Unobserved-at home

ACTIVE COMPARATOR

Buprenorphine Unobserved at home induction

Drug: Buprenorphine

Observed

ACTIVE COMPARATOR

Buprenorphine Observed in office induction

Drug: Buprenorphine

Interventions

Buprenorphine DRUG

Dose is determined according to the participants' individual need.

Also known as: Bup

Observed; Unobserved-at home

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• DSM-IV criteria for current opioid dependence with physical dependence and are seeking treatment
• Recent opioid use
• Individuals must describe opioids as their primary drug of abuse.
• years of age
• Able to give informed consent and comply with study procedures
• Financially able to receive treatment at AIM and obtain medication (e.g., Medicaid)

You may not qualify if:

• DSM-IV opioid dependence without physical dependence
• Any current Axis I psychiatric disorder(s) as defined by DSM-IV-TR that in the investigator's judgment are unstable or would be disrupted by study participation (e.g., psychosis, active suicidal or homicidal ideation).
• Individuals who are significant risk for suicide based on their current mental state or history.
• DSM-IV alcohol or benzodiazepine dependence with physiologic dependence.
• Pregnancy, lactation. Women must also agree to use a method of contraception with proven efficacy and agree not to become pregnant during the study.
• Unstable physical disorder that might make participation hazardous.
• Individuals with a known allergy, sensitivity or adverse reaction to buprenorphine.
• Past life-threatening idiosyncratic severe opioid withdrawal reaction (e.g., psychosis, seizure)
• Current buprenorphine maintenance
• Current long-acting opioid use (e.g., methadone)
• Inability to read or understand the self-report assessment forms unaided

Sponsors & Collaborators

• New York State Psychiatric Institute: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Columbia University/New York State Psychiatric Institute

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders; Heroin Dependence

Interventions

Buprenorphine

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Limitations and Caveats

The primary pilot study limitations are sample size and treatment setting, which restricts statistical comparison of outcomes and generalizability.

Results Point of Contact

• Title: Dr. Frances Levin
• Organization: New York State Psychiatric Institute

frl2@columbia.edu

646-774-6137

Study Officials

• Erik W Gunderson, M.D.

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Substance Use Disorder

Study Record Dates

• First Submitted: May 22, 2008
• First Posted: May 26, 2008
• Study Start: December 1, 2007
• Primary Completion: August 1, 2008
• Study Completion: April 1, 2010
• Last Updated: April 24, 2019
• Results First Posted: January 11, 2016

Record last verified: 2019-04

Locations

US (1)