"I go out of my way to give them an extra smile now:" A study of pharmacists who participated in Respond to Prevent, a community pharmacy intervention to accelerate provision of harm reduction materials.

BACKGROUND: Community pharmacies are well-positioned to improve the health of people with opioid use disorder and who use drugs by providing naloxone and other essential public health supplies. Respond to Prevent (R2P) is a clinical trial which sought to accelerate provision of harm reduction materials through a multicomponent intervention that included in-store materials, online training, and academic detailing. OBJECTIVES: The objective of this study was to explore pharmacists' attitudes, knowledge, and experiences in providing naloxone, dispensing buprenorphine, and selling nonprescription syringes following participation in the R2P program. METHODS: Two online asynchronous focus groups were conducted with community-based chain pharmacists across Massachusetts, New Hampshire, Oregon, and Washington who had participated in the R2P program. Participants accessed an online repository of group interview items and responded to questions over a short period. Each pharmacist participated anonymously for approximately 30 min over 2 ½ days. Pharmacists answered questions on experiences with pharmacy-based harm reduction care and R2P intervention implementation barriers and facilitators. Qualitative data analysis was conducted by a multidisciplinary team using an immersion-crystallization approach. RESULTS: A total of 32 pharmacists participated in the two focus groups. Most participants were female (n = 18, 56%), non-Hispanic (n = 29, 91%), and white (n = 17, 53%). Four major themes were identified related to (1) addressing bias and stigma toward people with opioid use disorder and who use drugs, (2) familiarity and comfort with naloxone provision, (3) perspective and practice shifts in nonprescription syringe sales, (4) structural challenges to harm reduction care in the pharmacy. CONCLUSIONS: Community pharmacists across the four states identified attitudes, knowledge, and experiences that create barriers to providing care to people with opioid use disorder and who use drugs. R2P approaches and tools were effective at reducing stigma and changing attitudes but were less effective at addressing structural challenges from the pharmacists' perspective.

The Cost of Safe Injection: Insights on Nonprescription Syringe Price Variability From Systematic Secret Shopping.

BACKGROUND: Although the sale of nonprescription syringes in pharmacies is legal in most states, people who inject drugs (PWID) continue to face obstacles to syringe purchase like stigma, prohibitive costs, restrictive policies, and stocking issues. We examined the consistency of syringe pricing as another possible barrier. METHODS: We analyzed data on syringe prices and other relevant variables from 153 unique secret shopper visits to 2 retail chain pharmacies in Massachusetts (MA), New Hampshire (NH), Oregon (OR), and Washington (WA) as part of the fidelity component of a large pharmacy-focused intervention study. Pretax prices from purchases made between August 2019 and May 2021 were adjusted for inflation to 2022 dollars, and a linear regression of the price of a 10-pack of syringes was constructed to examine the determinants of syringe pricing. RESULTS: The average real price of a 10-pack of syringes across all states was $4.53 (SD = 0.99), with wide variability between pharmacies (max = $11.44, min = $1.70) and between states (mean OR = $5.76, WA = $4.74, MA = $4.33, NH = $4.30). Forty-seven percent (n = 72) of the purchases were taxed despite syringes being tax exempt in MA and WA, and not having a sales tax in NH or OR. The results of the regression suggest that certain needle gauges were associated with lower overall prices, while 1 pharmacy chain and 2 syringe brands were associated with higher overall prices. CONCLUSIONS: The high variability in syringe pricing presents another barrier to pharmacy-based syringe access since high prices may leave PWID no choice but to reuse or share needles, especially in areas with limited alternatives or without a syringe service program. Leadership from healthcare systems, pharmacy chains, and state and local policymakers is essential to reduce stigma and to implement policies that streamline syringe purchases, eliminate the taxation of exempt syringes in accordance with state laws, and reduce the variation in syringe prices.

Pharmacy staff-reported adaptations to naloxone provision and over-the-counter (OTC) syringe sales during the COVID-19 pandemic: Experiences across multiple states and 2 pharmacy chains.

BACKGROUND: Access to harm reduction materials was greatly disrupted during coronavirus disease 2019 (COVID-19). Community pharmacies often continued provision of harm reduction materials as part of their usual operations during the pandemic, but little is known about what, if any, adaptations were made and the perceived impact of these actions from the perspective of pharmacy staff. OBJECTIVES: We explored how pharmacy staff across 4 states in 2 major pharmacy chains adapted to the COVID-19 pandemic for ongoing naloxone and over-the-counter (OTC) syringe access and how staff perceived the pandemic affected drug use in the community they served and their pharmacy's volume of syringe sales and naloxone provision. METHODS: We analyzed 134 pharmacy staff responses to a 12-month follow-up assessment for an educational intervention conducted in 2 pharmacy chains in Oregon, Washington, Massachusetts, and New Hampshire. Respondents answered closed- and open-ended questions collected online from July 2020 to February 2022. Questions measured prevalence of adaptations and perceived uptake of naloxone and OTC syringe services. Descriptive statistics summarized adaptations and perceived impact and chi-square tests explored differences by state and pharmacy chain. Open-ended responses were reviewed and analyzed to identify summary points and themes. RESULTS: With few differences by state or pharmacy chain detected, pharmacy staff reported more naloxone mailing, requests by phone, streamlined counseling, and drive-thru provision adaptations to OTC syringe sales and naloxone provision during the pandemic. Most staff perceived adaptations as increasing or maintaining naloxone provision and OTC syringe sales. Respondents described specific aspects of the pharmacy that contributed to successful adaptations, including tailoring to specific product demand, inventory levels, drive-thru access, and a perception of extraordinary public health need at a time of and in places affected by the opioid crisis. CONCLUSIONS: Pharmacy OTC syringe and naloxone access continued during the COVID-19 pandemic through streamlining workflows and innovating no-contact harm reduction services, reinforcing pharmacy's public health role.

"Like it was just everyday business": A qualitative study of pharmacy-based naloxone and syringe customer experience.

BACKGROUND: As rates of overdoses involving opioids continue to rise in the United States, community pharmacies are uniquely positioned as a central access point of care for individuals to access harm reduction supplies, such as naloxone and nonprescription syringes (NPS). OBJECTIVES: This study aimed to identify the facilitators and barriers of obtaining naloxone and NPS at community pharmacies that participated in Respond to Prevent (R2P), a multicomponent intervention to increase dispensing rates of naloxone, buprenorphine, and NPS. METHODS: Pharmacy customers were recruited to participate in semistructured qualitative interviews conducted immediately after they obtained, or attempted to obtain, naloxone and NPS (when applicable) from R2P-participating pharmacies. Thematic analysis was conducted on the transcribed interviews, and content coding was applied to ethnographic notes and text messages from participants. RESULTS: Of the 32 participants, most (n = 28, 88%) successfully obtained naloxone and most of those seeking NPS successfully (n = 14, 82%) purchased them as well. Participants reported positive overall experiences at the community pharmacies. Participants described using the intervention advertising materials, as designed, to facilitate the request for naloxone. Many participants shared that they felt respected by pharmacists and that they valued naloxone counseling sessions that were tailored to meet their needs and allowed space for them to ask questions. Barriers included experiences where the intervention did not address structural challenges that prohibited the purchase of naloxone and where certain types of staff lacked knowledge, treated participants poorly, or did not adequately provide expected naloxone counseling. CONCLUSION: Pharmacy customer experiences obtaining naloxone and NPS in R2P-participating pharmacies identify facilitators and barriers to access that may be used to reform implementation and future interventions. Barriers identified can help enhance strategies or inform policies to improve pharmacy-based harm reduction supply distribution not addressed through existing interventions.

Implementation of an academic detailing intervention to increase naloxone distribution and foster engagement in harm reduction from the community clinician.

BACKGROUND: Respond to Prevent (R2P) is a randomized clinical trial which sought to accelerate distribution of naloxone and other harm reduction materials from community pharmacies. R2P combined an online continuing education course with in-store materials, specifically designed for use in community pharmacies, and then supported implementation through the one-on-one educational technique of academic detailing. OBJECTIVE: The objective of this paper is to describe and synthesize our experiences providing academic detailing as part of the R2P randomized trial. METHODS: Closed-ended items from standardized post detailing questionnaires were analyzed with descriptive statistics. Open-ended items were content analyzed for key themes using immersion-crystallization qualitative methods. RESULTS: A total of 176 pharmacies participated in R2P with 175 receiving their initial academic detailing visit between August 2019 and May 2021. Initial visits were in-person and lasted a median of 35 minutes (interquartile range, 20-45 minutes). The R2P naloxone guide was the most common topic covered (n = 162, 92.6%). Following a fidelity check to assess adequacy of the R2P program implementation, 80 pharmacies (45.7%) required secondary academic detailing. Secondary detailing was more targeted and most frequently focused on the sale of nonprescription syringes (n = 28; 35.2%) or disposal container distribution (n = 30; 37.5%). Analysis of the open-ended items identified factors that the detailers perceived to affect the quality of academic detailing sessions, including the pharmacy environment, participant knowledge of and attitudes toward the subject matter, and ability of the detailer to remain flexible yet consistent. CONCLUSION: R2P provided a standardized process to foster naloxone distribution and engagement in harm reduction with demonstrated implementation in 175 community pharmacies across 4 states. Academic detailing was perceived to be well-received and effective at providing education and promoting distribution of naloxone and nonprescription syringes in community pharmacies. Additional research is needed to confirm these perceptions through evaluation post-intervention behavioral and attitude changes.

Readiness of community pharmacies to implement an opioid safety intervention.

BACKGROUND: We report on efforts to measure readiness to adopt opioid safety initiatives in community pharmacies within 2 large chains. Previous studies identified lack of knowledge, confidence, or enthusiasm in addressing harm reduction efforts. We implemented an intervention that provided training to improve opioid safety. The goal was to increase naloxone prescribing and nonprescription syringe sales, reduce stigma, and decrease opioid overdoses among patients and customers. OBJECTIVES: To assess pharmacy readiness for intervention delivery, by characterizing pharmacy culture around opioid safety; describing current practices and challenges interacting with patients and customers on naloxone, nonprescription syringe sales, and buprenorphine; and determining pharmacy defined goals for implementing the intervention. METHODS: The sample included pharmacy managers and staff pharmacists from 2 large chains who completed a brief phone interview. Interviews consisted of Likert-scale and open-ended, theoretically driven questions. Questions focused on workplace culture, patient engagement, naloxone and buprenorphine prescribing, nonprescription syringe sales, and intervention goals. Coding categories for the open-ended questions were derived using a thematic review of responses. RESULTS: A total of 163 respondents described both workplace culture and how they encourage patient opioid safety as including public health awareness, patient engagement, and naloxone prescribing. Sale of nonprescription syringes exhibited high variability: no sales barriers (53.9%), sales with barriers (21.5%), and no sales (20.9%). Half of pharmacists (50.3%) interacted with buprenorphine prescribers outside of medication fills. Most respondents (68.7%) endorsed being ready to promote the intervention. Pharmacists named goals in adopting the intervention of wanting more knowledge and educational materials, talking points with patients, and best practices for offering naloxone. CONCLUSION: Community pharmacists, before implementation, described awareness of and receptiveness to opioid safety initiatives, with substantial barriers around nonprescription syringe sales. Assessed knowledge level, culture, and identified barriers that emerged in the readiness assessments can be used to tailor future pharmacy-specific programming.

The Community-Based Medication-First program for opioid use disorder: a hybrid implementation study protocol of a rapid access to buprenorphine program in Washington State.

BACKGROUND: Opioid use disorder (OUD) is a serious health condition that is effectively treated with buprenorphine. However, only a minority of people with OUD are able to access buprenorphine. Many access points for buprenorphine have high barriers for initiation and retention. Health care and drug treatment systems have not been able to provide services to all-let alone the majority-who need it, and many with OUD report extreme challenges starting and staying on buprenorphine in those care settings. We describe the design and protocol for a study of a rapid access buprenorphine program model in six Washington State communities at existing sites serving people who are unhoused and/or using syringe services programs. This study aimed to test the effectiveness of a Community-Based Medication-First Program model. METHODS: We are conducting a hybrid effectiveness-implementation study of a rapid access buprenorphine model of care staffed by prescribers, nurse care managers, and care navigators. The Community-Based Medication-First model of care was designed as a 6-month, induction-stabilization-transition model to be delivered between 2019 and 2022. Effectiveness outcomes will be tested by comparing the intervention group with a comparison group derived from state records of people who had OUD. Construction of the comparison group will align characteristics such as geography, demographics, historical rates of arrests, OUD medication, and health care utilization, using restriction and propensity score techniques. Outcomes will include arrests, emergency and inpatient health care utilization, and mortality rates. Descriptive statistics for buprenorphine utilization patterns during the intervention period will be documented with the prescription drug monitoring program. DISCUSSION: Results of this study will help determine the effectiveness of the intervention. Given the serious population-level and individual-level impacts of OUD, it is essential that services be readily available to all people with OUD, including those who cannot readily access care due to their circumstances, capacity, preferences, and related systems barriers.

Barriers to recruitment, retention and intervention delivery in a randomized trial among patients with firearm injuries.

BACKGROUND: We discuss barriers to recruitment, retention, and intervention delivery in a randomized controlled trial (RCT) of patients presenting with firearm injuries to a Level 1 trauma center. The intervention was adapted from the Critical Time Intervention and included a six-month period of support in the community after hospital discharge to address recovery goals. This study was one of the first RCTs of a hospital- and community-based intervention provided solely among patients with firearm injuries. MAIN TEXT: Barriers to recruitment included limited staffing, coupled with wide variability in length of stay and admission times, which made it difficult to predict the best time to recruit. At the same time, more acutely affected patients needed more time to stabilize in order to determine whether eligibility criteria were met. Barriers to retention included insufficient patient resources for stable housing, communication and transportation, as well as limited time for patients to meet with study staff to respond to follow-up surveys. These barriers similarly affected intervention delivery as patients who were recruited, but had fewer resources to help with recovery, had lower intervention engagement. These barriers fall within the broader context of system avoidance (e.g., avoiding institutions that keep formal records). Since the patient sample was racially diverse with the majority of patients having prior criminal justice system involvement, this may have precluded active participation from some patients, especially those from communities that have been subject to long and sustained history of trauma and racism. We discuss approaches to overcoming these barriers and the importance of such efforts to further implement and evaluate hospital-based violence intervention programs in the future. CONCLUSION: Developing strategies to overcome barriers to data collection and ongoing participant contact are essential to gathering robust information to understand how well violence prevention programs work and providing the best care possible for people recovering from injuries. TRIAL REGISTRATION: ClinicalTrials.gov NCT02630225 . Registered 12/15/2015.

Neighborhood disadvantage and firearm injury: does shooting location matter?

BACKGROUND: Firearm violence is a public health problem that disparately impacts areas of economic and social deprivation. Despite a growing literature on neighborhood characteristics and injury, few studies have examined the association between neighborhood disadvantage and fatal and nonfatal firearm assault using data on injury location. We conducted an ecological Bayesian spatial analysis examining neighborhood disadvantage as a social determinant of firearm injury in Seattle, Washington. METHODS: Neighborhood disadvantage was measured using the National Neighborhood Data Archive disadvantage index. The index includes proportion of female-headed households with children, proportion of households with public assistance income, proportion of people with income below poverty in the past 12 months, and proportion of the civilian labor force aged 16 and older that are unemployed at the census tract level. Firearm injury counts included individuals with a documented assault-related gunshot wound identified from medical records and supplemented with the Gun Violence Archive between March 20, 2016 and December 31, 2018. Available addresses were geocoded to identify their point locations and then aggregated to the census tract level. Besag-York-Mollie (BYM2) Bayesian Poisson models were fit to the data to estimate the association between the index of neighborhood disadvantage and firearm injury count with a population offset within each census tract. RESULTS: Neighborhood disadvantage was significantly associated with the count of firearm injury in both non-spatial and spatial models. For two census tracts that differed by 1 decile of neighborhood disadvantage, the number of firearm injuries was higher by 21.0% (95% credible interval: 10.5, 32.8%) in the group with higher neighborhood disadvantage. After accounting for spatial structure, there was still considerable residual spatial dependence with 53.3% (95% credible interval: 17.0, 87.3%) of the model variance being spatial. Additionally, we observed census tracts with higher disadvantage and lower count of firearm injury in communities with proximity to employment opportunities and targeted redevelopment, suggesting other contextual protective factors. CONCLUSIONS: Even after adjusting for socioeconomic factors, firearm injury research should investigate spatial clustering as independence cannot be able to be assumed. Future research should continue to examine potential contextual and environmental neighborhood determinants that could impact firearm injuries in urban communities.

Helping individuals with firearm injuries: A cluster randomized trial.

BACKGROUND: Patients with firearm injuries are at high risk of subsequent arrest and injury following hospital discharge. We sought to evaluate the effect of a 6-month joint hospital- and community-based low-intensity intervention on risk of arrest and injury among patients with firearm injuries. METHODS: We conducted a cluster randomized controlled trial, enrolling patients with firearm injuries who received treatment at Harborview Medical Center, the level 1 trauma center in Seattle, Washington, were 18 years or older at the time of injury, spoke English, were able to provide consent and a method of contact, and lived in one of the five study counties. The intervention consisted of hospital-based motivational interviewing, followed by a 6-month community-based intervention, and multiagency support. The primary outcome was the risk of subsequent arrest. The main secondary outcome was the risk of death or subsequent injury requiring treatment in the emergency department or hospitalization. RESULTS: Neither assignment to or engagement with the intervention, defined as having at least 1 contact point with the support specialist, was associated with risk of arrest at 2 years post-hospital discharge (relative risk for intervention assignment, 1.15; 95% confidence interval, 0.90-1.48; relative risk for intervention engagement, 1.07; 95% confidence interval, 0.74-2.19). There was similarly no association observed for subsequent injury. CONCLUSIONS: This study represents one of the first randomized controlled trials of a joint hospital- and community-based intervention delivered exclusively among patients with firearm injuries. The intervention was not associated with changes in risk of arrest or injury, a finding most likely due to the low intensity of the program. LEVEL OF EVIDENCE: Care management, level II.

Fidelity Assessment of a Social Work-Led Intervention Among Patients with Firearm Injuries.

PURPOSE: To support future development and refinement of social work-led intervention programs among patients with firearm injuries and to demonstrate how a fidelity assessment can be used to adjust and refine intervention delivery in an ongoing trial. METHODS: We conducted a fidelity assessment of a randomized controlled trial of a social work-led intervention among patients with a firearm injury. RESULTS: We found that our study intervention was well implemented, meeting 70% of the fidelity assessment score items, however noted lower fidelity with client-based items. DISCUSSION: As a result of fidelity assessment findings, we refined intervention delivery to improve implementation fidelity including beginning to review cases of all patients each month, rather than focusing on patients in crisis. Our fidelity assessment process and findings offer insight into the challenges of implementing an intervention among patients with firearm injuries and highlights the value of monitoring intervention fidelity during an ongoing trial.

Opioid Use Disorder Treatment Decision Making And Care Navigation Upon Release From Prison: A Feasibility Study.

PURPOSE: Opioid use disorder (OUD) is a medical condition that is effectively treated with medications. A major challenge in breaking the cycle of OUD and related illegal activity is seamlessly introducing medications for opioid use disorder (MOUD) as individuals leave jail or prison. We examined the feasibility of a pilot intervention to link participants to ongoing MOUD and psychosocial supports following release from custody. METHODS: The study enrolled adults with a history of OUD released from Washington State prisons to Department of Corrections (DOC) community supervision. Participants were randomized to the study intervention or comparison group. The intervention consisted of education on OUD and available treatments, support with individualized treatment decision making, and continued care navigation for 6 months to facilitate linkage to chosen treatments. Participants randomized to the control condition received referral to services in the community from their community corrections officers. A care navigation activity log documented intervention participants' intervention engagement, service utilization, and needs. Follow-up interviews were conducted at 1 and 6 months to assess satisfaction with the intervention. RESULTS: Fifteen participants were enrolled. All were male, most were white (86.6%) and the average age was 36.9 years. The majority (14 of 15 participants) were near-daily heroin users with severe OUD prior to incarceration. Of the seven intervention participants, two wished to start medications immediately. Three participants reported starting buprenorphine or methadone in the subsequent follow-up period, with or without social support and/or outpatient counseling, and three reported enrolling in social support and/or outpatient counseling without medications. Participants who received the intervention reported high satisfaction. We discuss barriers and facilitators to study implementation. CONCLUSION: An intervention to link participants to ongoing MOUD and psychosocial supports following release from prison had broad acceptability among participants and was feasible to implement among those recruited; however, enrollment was much lower than anticipated and the study intervention did not demonstrate the intended effect to facilitate use of MOUD immediately post-release in this small sample of participants. Given recent research showing benefits of pre-release medication initiation, the potential added benefits of this two-part intervention should be studied in systems that initiate MOUD prior to release.

Firearm-related behaviors following firearm injury: changes in ownership, carrying and storage.

Individuals who sustain nonfatal gunshot wound (GSW) injuries are at substantially increased risk of subsequent firearm injury. There is a dearth of literature examining what, if any, firearm-related behavior changes occur among adults as a result of GSW injuries. Using survey data on firearm-related behaviors from an ongoing randomized controlled trial, we sought to describe changes in reported firearm-related behaviors among GSW patients following their injury. Our results suggest that patients with a GSW, especially firearm owners, may change their firearm-related behaviors following injury, some by increasing firearm-related safety and others by increasing frequency of behaviors that may place them at increased risk of subsequent injury. This study highlights the need for further examination of firearm-related behavior change among GSW patients and development of interventions to promote firearm safety among this population.

Impacts of an opioid overdose prevention intervention delivered subsequent to acute care.

BACKGROUND: Opioid overdose is a major and increasing cause of injury and death. There is an urgent need for interventions to reduce overdose events among high-risk persons. METHODS: Adults at elevated risk for opioid overdose involving heroin or pharmaceutical opioids who had been cared for in an emergency department (ED) were randomised to overdose education combined with a brief behavioural intervention and take-home naloxone or usual care. Outcomes included: (1) time to first opioid overdose-related event resulting in medical attention or death using competing risks survival analysis; and (2) ED visit and hospitalisation rates, using negative binomial regression and adjusting for time at risk. RESULTS: During the follow-up period, 24% of the 241 participants had at least one overdose event, 85% had one or more ED visits and 55% had at least one hospitalisation, with no significant differences between intervention and comparison groups. The instantaneous risk of an overdose event was not significantly lower for the intervention group (sub-HR: 0.83; 95% CI 0.49 to 1.40). DISCUSSION: These null findings may be due in part to the severity of the population in terms of housing insecurity (70% impermanently housed), drug use, unemployment and acute healthcare issues. Given the high overdose and healthcare utilisation rates, more intensive interventions, such as direct referral and provision of housing and opioid agonist treatment medications, may be necessary to have a substantial impact on opioid overdoses for this high-acuity population in acute care settings. TRIAL REGISTRATION NUMBER: NCT0178830; Results.

Stimulant abuser groups to engage in 12-step: a multisite trial in the National Institute on Drug Abuse Clinical Trials Network.

AIMS: The study evaluated the effectiveness of an 8-week combined group plus individual 12-step facilitative intervention on stimulant drug use and 12-step meeting attendance and service. DESIGN: Multisite randomized controlled trial, with assessments at baseline, mid-treatment, end of treatment, and 3- and 6-month post-randomization follow-ups (FUs). SETTING: Intensive outpatient substance treatment programs. PARTICIPANTS: Individuals with stimulant use disorders (n = 471) randomly assigned to treatment as usual (TAU) or TAU into which the Stimulant Abuser Groups to Engage in 12-Step (STAGE-12) intervention was integrated. MEASUREMENTS: Urinalysis and self-reports of substance use and 12-step attendance and activities. INTERVENTION: Group sessions focused on increasing acceptance of 12-step principles; individual sessions incorporated an intensive referral procedure connecting participants to 12-step volunteers. FINDINGS: Compared with TAU, STAGE-12 participants had significantly greater odds of self-reported stimulant abstinence during the active 8-week treatment phase; however, among those who had not achieved abstinence during this period, STAGE-12 participants had more days of use. STAGE-12 participants had lower Addiction Severity Index Drug Composite scores at and a significant reduction from baseline to the 3-month FU, attended 12-step meetings on a greater number of days during the early phase of active treatment, engaged in more other types of 12-step activities throughout the active treatment phase and the entire FU period, and had more days of self-reported service at meetings from mid-treatment through the 6-month FU. CONCLUSIONS: The present findings are mixed with respect to the impact of integrating the STAGE-12 intervention into intensive outpatient drug treatment compared with TAU on stimulant drug use. However, the results more clearly indicate that individuals in STAGE-12 had higher rates of 12-step meeting attendance and were engaged in more related activities throughout both the active treatment phase and the entire 6-month FU period than did those in TAU.

How practice and science are balanced and blended in the NIDA Clinical Trials Network: the bidirectional process in the development of the STAGE-12 protocol as an example.

BACKGROUND: Bidirectional, collaborative partnerships between academic researchers and practitioners have been a fundamental vehicle to achieve the National Institute on Drug Abuse (NIDA) Clinical Trials Network (CTN) goal of improving outcomes of community-based drug treatment. These partnerships blend clinical perspectives of practitioners and methodological expertise of researchers working together to address clinically meaningful issues through randomized clinical trials conducted in community treatment settings. OBJECTIVES: Bidirectionality is a guiding principle of the CTN, but its operationlization at the practical level in protocol development and implementation has not been articulated. This descriptive article presents the development of one protocol as an example and model of this bidirectional, collaborative, iterative partnership between researchers and practitioners. METHODS: This article illuminates several specific issues encountered while developing STAGE-12, a behavioral intervention to facilitate 12-step mutual support group involvement, as well as the rationale for decisions taken to resolve each. RESULTS: The STAGE-12 protocol was successfully developed through a series of decisions taking into account both design factors and clinical practice needs and realities, thus maintaining a balance between methodological rigor and generalizability. CONCLUSION: The review demonstrates the process by which research and practice have been blended in protocol development, exemplifying the underlying principle of bidirectionality, a key element in the success of the NIDA CTN. SCIENTIFIC SIGNIFICANCE: Bidirectional partnerships as derived in the CTN, employing a hybrid model of efficacy-effectiveness research, are capable of designing and implementing protocols that are both methodologically rigorous and clinically meaningful, thus increasing likelihood of adoption and eventual improvement in public health.

Facilitating involvement in twelve-step programs.

Twelve-step programs represent a readily available resource for individuals with substance use disorders. These programs have demonstrated considerable effectiveness in helping substance abusers achieve and maintain abstinence and improve their overall psychosocial functioning and recovery. Despite these positive benefits associated with increased involvement in twelve-step self-help programs, many substance abusers do not affiliate or do so for only a short period of time before dropping out. Because of this, clinicians and researchers have sought ways to increase involvement in such self-help groups by facilitating meeting attendance and engagement in other twelve-step activities. The present chapter reviews the impact of treatment program orientation and specific interventions designed to facilitate twelve-step program involvement, subsequent meeting attendance, engagement in twelve-step activities, and alcohol and drug use. The findings of studies evaluating these approaches indicate that it is possible to increase twelve-step involvement and that doing so results in reduced substance use. The results suggest that incorporating these evidence-based interventions into standard treatment programs may lead to improved outcomes.