Heroin Dependence, Opioid-Related Disorders
Conditions
Keywords
Heroin Dependence, Opioid Dependence, Primary Care, Buprenorphine
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.
Interventions
DRUGBuprenorphine
Dose is determined according to the participants' individual need.
Sponsors
National Institute on Drug Abuse (NIDA)
New York State Psychiatric Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Primary Outcome Will Include a Comparison of the Proportion of Patients Successfully Inducted One Week After the Initial Primary Care Visit. | one week after 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Prolonged Withdrawal | a) 2 days | participants experiencing prolonged withdrawal beyond two days after buprenorphine induction |
Countries
United States
Participant flow
Recruitment details
Twenty patients were recruited between December 2007-June 2008 through referrals from clinical and research groups at Columbia University Medical Center and locally posted flyers.
Pre-assignment details
After a structured telephone interview, participants completed in-person screening after obtaining informed consent. Of the 21 patients screened, one was excluded for active alcohol and benzodiazepine dependence.
Participants by arm
| Arm | Count |
|---|---|
| Unobserved-at Home Buprenorphine Unobserved at home induction
Buprenorphine: Dose is determined according to the participants' individual need. | 10 |
| Observed Buprenorphine Observed in office induction
Buprenorphine: Dose is determined according to the participants' individual need. | 10 |
| Total | 20 |
Baseline characteristics
| Characteristic | Unobserved-at Home | Observed | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants | 10 Participants | 20 Participants |
| Region of Enrollment United States | 10 participants | 10 participants | 20 participants |
| Sex: Female, Male Female | 1 Participants | 1 Participants | 2 Participants |
| Sex: Female, Male Male | 9 Participants | 9 Participants | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 3 / 10 | 3 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 |
Outcome results
Primary
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.
Time frame: one week after initial primary care visit
Population: patients who in initiated induction
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Unobserved-at Home | The Primary Outcome Will Include a Comparison of the Proportion of Patients Successfully Inducted One Week After the Initial Primary Care Visit. | 6 participants |
| Observed | The Primary Outcome Will Include a Comparison of the Proportion of Patients Successfully Inducted One Week After the Initial Primary Care Visit. | 6 participants |
Secondary
Prolonged Withdrawal
participants experiencing prolonged withdrawal beyond two days after buprenorphine induction
Time frame: a) 2 days
Population: participants who initiated induction
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Unobserved-at Home | Prolonged Withdrawal | 3 participants |
| Observed | Prolonged Withdrawal | 3 participants |