Opiate Addiction
Conditions
Keywords
opioid dependence, buprenorphine, brief intervention
Brief summary
Patients with heroin and prescription opioid dependence are at increased risk for adverse health consequences and often utilize the Emergency Department (ED) as their source of medical care. Screening, brief intervention and referral to treatment has been effective in decreasing high risk behaviors such as alcohol and tobacco use, and unsafe sexual practices. The data on the effectiveness of brief interventions with opioid dependence is limited. This prospective, randomized controlled trial of opioid dependent subjects (N=360) will compare two models of brief intervention with a control condition. ED patients with opioid dependence will be randomized to either: (1)Screening, Brief Intervention with a Facilitated Referral to Treatment (SBIRT); (2) Screening, Brief Intervention with ED initiated Buprenorphine Treatment (SBI+Bup); or (3) standard care (SC) which includes a handout detailing substance abuse treatment centers in the area. The primary outcome will be self-reported engagement in formal substance abuse treatment at 30 days, verified by contact with the treatment program. Other outcomes measured at 30 days, 2, 6 and 12 months include changes in opioid use (self-report and urine toxicology analysis), HIV risk behaviors, and health care service utilization. The three interventions will also be compared on their cost-effectiveness. We will test the hypotheses that SBI+Bup will be superior to SBIRT and SC, and SBIRT will be superior to SC in (1)increasing the proportion of patients engaged in formal substance abuse treatment at 30 days; (2) reducing illicit opioid use; (3) reducing HIV risk behaviors; and (4) reducing health care service utilization. In addition, we hypothesize that the societal costs of SBI+Bup, per number of days of opioid abstinence, will be cost effective relative to SBIRT or SC; and that SBIRT will be cost effective relative to SC. Data analyses will be conducted on the intention to treat sample of randomized patients. This study, conducted by a research team with extensive experience evaluating brief interventions and treatments for opioid dependence, will be unique in its: (1) comparison of two models of brief intervention with standard care; (2) inclusion of an ED initiated treatment arm; (3) use of manual-guided interventions with systematic assessment of adherence and competence; and (4)collection of detailed cost data to help guide future healthcare policy.
Interventions
BEHAVIORALBrief Negotiation Interview (BNI)
Brief Negotiation Interview (BNI) is a manual-guided therapy that is designed to be feasible in the ED setting. The purpose of the BNI is to assist patients in recognizing and changing their drug use and HIV risk behaviors. It combines techniques based on motivational interviewing and a stage-model of change. The main goal of the interview is to decrease the subject's ambivalence about signing up for a formal drug treatment program.
DRUGBuprenorphine Initiation
Sponsors
National Institute on Drug Abuse (NIDA)
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients who present to the adult ED at Yale-New Haven Hospital (YNHH) who are: 1. 18 years or older, 2. meet criteria for opioid dependence as measured by the Mini-SCID, and 3. have a positive urine toxicology for opiates.
Exclusion criteria
* Inability to read or understand English * Currently receiving formal substance abuse treatment * Current suicide or homicidal risk * Current psychotic disorder * Life-threatening or unstable medical or psychiatric condition requiring hospital admission * Unable to provide 2 phone contact numbers * Unwilling to be randomized and/or follow up as per study protocol, including release of information to assess treatment engagement at 30-days * Requiring opioid agonist medication for a pain-related diagnosis (contraindication to buprenorphine)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Self-reported Engagement in Formal Substance Abuse Treatment at 30 Days (Verified by Contact With the Treatment Program) | 30 days post randomization | Defined as enrollment and receiving formal addiction treatment on the 30th day following randomization. This is assessed by direct contact with facility, clinician, or both. |
Secondary
| Measure | Time frame |
|---|---|
| Days of Self-reported Illicit Opioid Use in the Past 7 Days | 30 days post randomization |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Standard Care Standard Care including receiving a referral. | 104 |
| SBIRT Screening, Brief Intervention and Facilitated Referral to Treatment
Brief Intervention: Brief Negotiated Intervention (BNI) is a manual-guided therapy that is designed to be feasible in the ED setting. The purpose of the BNI is to assist patients in recognizing and changing their drug use and HIV risk behaviors. It combines techniques based on motivational interviewing and a stage-model of change. The main goal of the interview is to decrease the subject's ambivalence about signing up for a formal drug treatment program. | 111 |
| SBI+Bup Screening, Brief Intervention and Buprenorphine initiation
Brief Intervention with Buprenorphine initiation: Brief Negotiated Intervention is a manual-guided therapy designed for ED setting. Purpose- to assist patients recognize/change drug use and HIV risks. It combines techniques based on motivational interviewing and a stage-model of change. Goal- to decrease subject's ambivalence about accepting ED initiated buprenorphine treatment. Patients inducted onto buprenorphine in ED or home, based on level of withdrawal. ED induction goal- 8 mg first day. Home induction goal- 8 mg first day. Subjects receive supportive counseling and education by trained nurses in the PCC (seen within 24-72 hours of their ED visit). Following an initial 45-minute evaluation, the physician will administer Primary Care Management (PCM) weekly for 2 weeks, then every 2 weeks for 4 weeks and then monthly. | 114 |
| Total | 329 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Refused | 11 | 10 | 8 |
| Overall Study | Unable to contact | 24 | 19 | 13 |
Baseline characteristics
| Characteristic | Standard Care | SBIRT | SBI+Bup | Total |
|---|---|---|---|---|
| Age, Continuous | 31.4 years STANDARD_DEVIATION 10.6 | 31.9 years STANDARD_DEVIATION 9.7 | 31 years STANDARD_DEVIATION 9.8 | 31.4 years STANDARD_DEVIATION 10.6 |
| Sex: Female, Male Female | 23 Participants | 27 Participants | 28 Participants | 78 Participants |
| Sex: Female, Male Male | 81 Participants | 84 Participants | 86 Participants | 251 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 104 | 0 / 111 | 0 / 114 |
| serious Total, serious adverse events | 0 / 104 | 0 / 111 | 0 / 114 |
Outcome results
Primary
Self-reported Engagement in Formal Substance Abuse Treatment at 30 Days (Verified by Contact With the Treatment Program)
Defined as enrollment and receiving formal addiction treatment on the 30th day following randomization. This is assessed by direct contact with facility, clinician, or both.
Time frame: 30 days post randomization
Population: All subjects who were randomized to receive treatment were included in the primary analysis. 2 subjects were lost to follow up in the standard of care arm which is why 102 are included in the analysis instead of 104
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Standard Care | Self-reported Engagement in Formal Substance Abuse Treatment at 30 Days (Verified by Contact With the Treatment Program) | 4.99 Mean Number of Outpatient Visits |
| SBIRT | Self-reported Engagement in Formal Substance Abuse Treatment at 30 Days (Verified by Contact With the Treatment Program) | 5.67 Mean Number of Outpatient Visits |
| SBI+Bup | Self-reported Engagement in Formal Substance Abuse Treatment at 30 Days (Verified by Contact With the Treatment Program) | 3.71 Mean Number of Outpatient Visits |
Secondary
Days of Self-reported Illicit Opioid Use in the Past 7 Days
Time frame: 30 days post randomization
Population: All subjects who were randomized to receive treatment were included in the primary analysis. 2 subjects were lost to follow up in the standard of care arm which is why 102 are included in the analysis instead of 104
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Standard Care | Days of Self-reported Illicit Opioid Use in the Past 7 Days | 2.3 Mean Number of Days |
| SBIRT | Days of Self-reported Illicit Opioid Use in the Past 7 Days | 2.4 Mean Number of Days |
| SBI+Bup | Days of Self-reported Illicit Opioid Use in the Past 7 Days | 0.9 Mean Number of Days |