SM Meli, TP Palfai, DM Cheng, DP Alford, JA Bernstein, JH Samet, CA Lloyd-Travaglini, CE Chaisson, R Saitz Screening and brief intervention for low risk drug use in primary care: A pilot randomized trial AMERSA Conference 2015 Schools of Public Health and Medicine

 The US Preventive Services Task Force (USPSTF) recommends brief intervention (BI) for primary care patients with unhealthy alcohol use identified by screening. 1  Federal efforts support “SBIRT” dissemination. SBIRT includes Screening and BI, and Referral and Treatment, for alcohol and other drugs.  “The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of screening adolescents, adults, and pregnant women for illicit drug use.” 2  U niversal screening and brief intervention (SBI) for moderate/high risk drug use among primary care (PC) patients lacks efficacy but the efficacy of SBI for low risk drug use is unknown. INTRODUCTION 1 U.S. Preventive Services Task Force, Agency for Healthcare Research and Quality (2013). Screening and Behavioral Counseling Interventions in Primary Care To Reduce Alcohol Misuse: Recommendation Statement. Ann Intern Med 140(7): doi: / U.S. Preventive Services Task Force (2008). Screening for Illicit Drug Use: U.S. Preventive Services Task Force Recommendation Statement. Retrieved from:

 We tested the efficacy of brief intervention (BI) for low risk drug use among primary care (PC) patients identified by screening.  An exploratory aim was to assess whether effects differed by main drug. AIM

 Design:  Pilot randomized controlled trial with 3 arms.  Subjects:  Adults in primary care at an urban medical center screened by trained personnel; Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST) drug-specific involvement score of 2 or 3 (i.e. low risk drug use).  A score of 2=use of main drug once or twice, in the past 3 months.  A score of 3=use of main drug monthly, in the past 3 months. METHODS

 Groups: 1.No Brief Intervention (No BI). 2.Brief Negotiated Interview (BNI): minute structured interview conducted by trained health educators. 3.Adaptation of Motivational Interviewing (MOTIV): ≤45 minutes of motivational interviewing and an optional booster conducted by trained masters-level counselors. INTERVENTION

 18 years or older.  Arrived for a primary care visit.  ASSIST drug-specific involvement score of 2 or 3.  Drug use in the past 3 months.  No previous MASBIRT intervention in the past 3 months.  Fluent in English or Spanish.  2 contacts who can assist in locating the subject for follow- up.  Able to return to Boston Medical Center in the next 6 months.  Not pregnant (for female subjects).  Able to be interviewed by trained research staff (excluding those in acute discomfort or with significantly impaired cognition). INCLUSION CRITERIA

 Primary Outcome:  # days use of main drug* in past 30 days at 6-months.  Secondary Outcome:  Drug use consequences at 6-months.  Measured by the Short Inventory of Problems–Drugs (SIP-D).  Analyses:  Negative binomial regression models, adjusted for baseline use and main drug*. METHODS *Main drug is the drug of most concern.

ENROLLMENT & FOLLOW-UP Persons potentially available for screening 1504 Randomized 61/142 (43%) Followed up at 6 months 57/61 (93%) BNI group 23No BI group 19 MOTIV group 19 Screened 1287 Of those with drug use identified by screening, total eligible for pilot study 142

RESULTS BASELINE CHARACTERISTICS Characteristic% (n) Race/ethnicity Black or African American Hispanic or Latino White Other 77 (47) 5 (3) 16 (10) 2 (1) Mean age (SD)41 (13) Male54 (33) 1+ nights in shelter OR on street in past 3 months11 (7) High school graduate or higher77 (47) PHQ-9** score >10 (mod to severe depressive symptoms)21 (13) OASIS # score > 8 (clinically significant anxiety)28 (17) Any outpatient counseling (doctor, nurse, or other health professional) or mutual help during past 3 months for alcohol, drugs or mental health* 20 (12) *There were no significant differences between groups at baseline except for outpatient or self-help treatment **PHQ-9 = Patient Health Questionnaire depression module # OASIS = Overall Anxiety Severity and Impairment Scale (OASIS)

RESULTS BASELINE CHARACTERISTICS DRUG USE: Main Drug ## % (n) Prescription Opioids10 (6) Cocaine15 (9) Marijuana70 (43) Other Drug5 (3) Days Use of Main Drug (in past 30)Mean (SD) = 3.4 (5) Injected Drugs (past 3 Months)7 (4) Use of more than 1 drug in past three months25 (15) Misuse of any RX drug in past three months15 (9) ASSIST Score of 274 (45) ASSIST Score of 326 (16) ALCOHOL USE: Any heavy drinking days in past month (Women 4+ drinks/day, Men 5+ drinks/day) 49 (30) ## Drug of most concern, as determined by the participant

PRIMARY OUTCOME RESULTS (# DAYS USED MAIN DRUG IN PAST 30 DAYS AT 6 MONTHS) No BIBNIMOTIVBNI vs. no BIMOTIV vs. no BI N Adjusted Means IRR (95% CI) p-value IRR (95% CI) p-value Days used main drug (0.15,0.74) (0.15,0.85) 0.02 Exploratory analyses stratified by main drug Days used main drug ‡ (Cocaine, Opioids §, and Other) (0.03,0.43) (0.17,3.91) 0.79 Days used main drug ‡ (Marijuana) (0.19,1.25) (0.15,1.14) Model adjusted for the following baseline covariates: # days main drug use in past 30 and main drug ‡ Model adjusted for the following baseline covariates: # days main drug use in past 30 § Opioid use does not include heroin

No BIBNIMOTIVBNI vs. no BIMOTIV vs. no BI N Adjusted Means IRR (95% CI) p- value IRR (95% CI) p-value SIP-D (0.20,5.60) (0.05,1.92) 0.41 Exploratory analyses stratified by main drug SIP-D ‡ (Cocaine, Opioids §, and Other) (0.04,4.13) (0.02,3.63) 0.45 SIP-D ‡ (Marijuana) (0.10,11.33) (0.05,12.46) Model adjusted for the following baseline covariates: SIP-D and main drug ‡ Model adjusted for the following baseline covariates: SIP-D § Opioid use does not include heroin in this sample SIP-D=Short Inventory of Problems, Drug SECONDARY OUTCOME RESULTS (SIP-D AT 6 MONTHS )

 All audible intervention recordings were coded using both the MITI and an ASPIRE-study-developed instrument.  Both had scores consistent with proficiency. FIDELITY OF THE INTERVENTION * MITI=motivational interviewing treatment integrity

 Effectiveness design choices: No exclusions for heavy drinking, multiple drug use, or comorbidity.  May have limited applicability beyond urban hospital-based primary care.  Likely underpowered especially to detect effects within subgroups and for drug use consequences.  Hair testing results not reported herein; however, results for tetrahydrocannabinol were consistent with self report findings.  Fewer than half of those eligible enrolled (and small sample), potentially limiting conclusions regarding effectiveness and generalizability. LIMITATIONS

 BNI and MOTIV appear to have efficacy for preventing an increase in drug use in primary care patients with low risk use identified by screening.  We did not detect an effect of BI on drug use-related problems, though problem scores were already low at study entry. CONCLUSION

 Less severe patterns of drug use in primary care may be uniquely amenable to brief intervention.  Findings warrant replication in a larger trial. IMPLICATIONS

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