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

NCT ID: NCT00684554

Last Updated: 2019-04-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-12-31
• Study Completion Date: 2010-04-30

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.

Detailed Description

Buprenorphine maintenance is an effective treatment for opioid dependence, yet diffusion has been limited. Physician concern about induction is a reported barrier, primarily as buprenorphine may precipitate withdrawal due to its partial opioid agonist activity and high receptor binding affinity. To minimize risk, guidelines recommend in-office assessment and monitoring during induction. As this may not be feasible (e.g., time limitations), many patients are instructed to self-induct at home. While this may facilitate treatment entry, data on at-home induction are limited. 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. Currently, patients receive buprenorphine maintenance at AIM as part of standard clinical practice and through an observational study (IRB 5258). Most patients are insured through Medicaid, which covers visit, medication (obtained through prescription from a local pharmacy), lab, and outside psychosocial treatment cost. In this demonstration project, 20 opioid dependent patients will be randomly assigned to at-home or in-office induction, and then monitored for 12 weeks. Ancillary psychosocial treatment will be encouraged but not required. After randomization, AIM clinic and NYSPI research visits will be scheduled weekly for 4 weeks, and then at weeks 8 and 12. The primary outcome will include a comparison of the proportion of patients successfully inducted one week after the initial primary care visit. Secondary outcomes will include: 1) Time to stabilization after buprenorphine initiation assessed by: a) Time until the patient is without withdrawal for two consecutive days, and b) Time until the patient is opioid free for two consecutive weeks; and 3) Retention-in-treatment at 4 and 12 weeks. Other secondary outcomes include patient satisfaction and change in addiction severity. These data will provide important information in buprenorphine initiation in primary care and enable determination of treatment effects size prior to future clinical trials.

Conditions

Opioid-Related Disorders; Heroin Dependence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Unobserved-at home

Buprenorphine Unobserved at home induction

Group Type: ACTIVE_COMPARATOR

Buprenorphine

Intervention Type: DRUG

Dose is determined according to the participants' individual need.

Observed

Buprenorphine Observed in office induction

Group Type: ACTIVE_COMPARATOR

Buprenorphine

Intervention Type: DRUG

Dose is determined according to the participants' individual need.

Interventions

Buprenorphine

Dose is determined according to the participants' individual need.

Intervention Type: DRUG

Other Intervention Names

Bup

Eligibility Criteria

Inclusion Criteria

1. DSM-IV criteria for current opioid dependence with physical dependence and are seeking treatment

2. Recent opioid use

3. Individuals must describe opioids as their primary drug of abuse.

4. 18-65 years of age

5. Able to give informed consent and comply with study procedures

6. Financially able to receive treatment at AIM and obtain medication (e.g., Medicaid)

Exclusion Criteria

1. DSM-IV opioid dependence without physical dependence

2. 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).

3. Individuals who are significant risk for suicide based on their current mental state or history.

4. DSM-IV alcohol or benzodiazepine dependence with physiologic dependence.

5. Pregnancy, lactation. Women must also agree to use a method of contraception with proven efficacy and agree not to become pregnant during the study.

6. Unstable physical disorder that might make participation hazardous.

7. Individuals with a known allergy, sensitivity or adverse reaction to buprenorphine.

8. Past life-threatening idiosyncratic severe opioid withdrawal reaction (e.g., psychosis, seizure)

9. Current buprenorphine maintenance

10. Current long-acting opioid use (e.g., methadone)

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

New York State Psychiatric Institute

OTHER

Sponsor Role: lead

Responsible Party

Frances R Levin

Director of Substance Use Disorder

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Erik W Gunderson, M.D.

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

Columbia University/New York State Psychiatric Institute

New York, New York, United States

Countries

United States

Other Identifiers

K23DA020000

Identifier Type: NIH

Identifier Source: secondary_id

View Link

#5600

Identifier Type: -

Identifier Source: org_study_id