Engaging people who use drugs in clinical research: integrating facilitated telemedicine for HCV into substance use treatment.

BACKGROUND: People who use drugs (PWUD) have difficulty participating in clinical research. We evaluated approaches to engage PWUD in clinical research, using facilitated telemedicine for hepatitis C virus (HCV) care as an example. METHODS: We analyzed stakeholder interview transcripts and study-related data (i.e., progress reports, meeting minutes) from interrelated studies to understand engagement experiences at the patient, site, and organizational levels. Stakeholders include patient-participants, opioid treatment program (OTP) staff and administrators, and research team members involved in HCV management through facilitated telemedicine integrated into OTPs. RESULTS: Three themes emerged. Initially, the research team sought understanding of the unique culture and community of each OTP (Theme 1). The team built trusting relationships through education, communication, and feedback (Theme 2). Finally, the research team enhanced collaborative care and incorporated the patients' voice to improve health outcomes (Theme 3). Patient-participants and OTP staff endorsed the integrated HCV care approach. Engagement practices are summarized as the CREATE framework (C = culture, R = respect, E = educate, A = advantage, T = trust, E = endorse). CONCLUSIONS: PWUD engagement in clinical research is maximized by building trusting relationships with open communication channels. Understanding the community, demonstrating respect, and augmenting knowledge are foundational for engaging PWUD in clinical research. These practices are transferable to engagement of PWUD in clinical research broadly.

People who use drugs rarely join clinical research studies for many reasons including mistrust of researchers and lack of access to healthcare. Their joining, however, is critical to understand how to address issues affecting their communities. For ten years, we have studied telemedicine (doctor visit through a computer) to increase healthcare access for people who use drugs with hepatitis C virus (HCV). HCV infection occurs commonly in people who use drugs and is curable in almost everyone who takes treatment. We place HCV treatment through facilitated telemedicine into drug treatment programs. A case manager who is familiar to patients oversees the telemedicine encounter with the doctor. We developed themes from interviews with patients, staff, and other involved people as well as from study documents. As a first step, researchers need to understand the culture and community of the drug treatment program. Knowing the culture permits researchers to connect the goals of the study with those of the drug treatment program. It also helps researchers build trust with the program staff. We have seen that trust between the researchers and the staff in the drug treatment program permits individuals with different jobs to work together to deliver HCV treatment resulting in a cure. During the entire process, a patient advisory committee made sure the patients were partners in the research. Based upon these results, we have developed a new approach, CREATE (C = Culture, R = respect, E = educate, A = advantage, T = trust, E = endorse), that explains each step in the process.

Evaluation of knowledge and confidence following opioid overdose prevention training: A comparison of types of training participants and naloxone administration methods.

BACKGROUND: The purpose of the current study was to assess the effect of opioid overdose prevention training on participants' knowledge about opioid overdose and confidence to recognize and respond to opioid overdose situations as a function of naloxone administration (i.e., injection vs. intranasal spray) and participant type (friend/family, provider, "other"). METHODS: Opioid overdose prevention trainings were offered throughout a mid-sized metropolitan area in the northeast. Participants (n = 428) were trained to administer naloxone via intramuscular injection (n = 154) or intranasal spray (n = 274). All training participants were given pre-post assessments of knowledge about opioid overdose and confidence to recognize and respond to opioid overdose situations. RESULTS: Participants' overall knowledge and confidence increased significantly from pre- to post-training (ps < .001). There was no significant association between knowledge and route of administration or participant type. Knowledge significantly increased from pre- to post-training in all participant types (ps < .001). Confidence improved significantly from pre- to post-training across both routes of administration (ps < .001). However, confidence was higher among those who were trained using the intranasal naloxone compared to those who were trained using the intramuscular injection naloxone at pre- (p = .011) and post-training (p < .001). Confidence increased from pre- to post-training in each of the participant types (ps < .001). Post-hoc tests revealed that confidence was higher among providers and friends/family members compared to "other" participants, such as first responders, only at post-training (p < .05). CONCLUSIONS: Opioid overdose trainings are effective in increasing knowledge and confidence related to opioid overdose situations. Findings suggest that trainees are more confident administering naloxone via intranasal spray compared to injection. Future research should attempt to identify other factors that may increase the likelihood of trainees' effectively intervening in opioid overdose situations.

Monocarboxylate Transporter Inhibition with Osmotic Diuresis Increases γ-Hydroxybutyrate Renal Elimination in Humans: A Proof-of-Concept Study.

BACKGROUND AND OBJECTIVE: The purpose of the current study was to demonstrate proof-of-concept that monocarboxylate transporter (MCT) inhibition with L-lactate combined with osmotic diuresis increases renal clearance of γ-hydroxybutyrate (GHB) in human subjects. GHB is a substrate for human and rodent MCTs, which are responsible for GHB renal reabsorption, and this therapy increases GHB renal clearance in rats. METHODS: Ten healthy volunteers were administered GHB orally as sodium oxybate 50 mg/kg (4.5 gm maximum dose) on two different study days. On study day 1, GHB was administered alone. On study day 2, treatment of L-lactate 0.125 mmol/kg and mannitol 200 mg/kg followed by L-lactate 0.75 mmol/kg/hr was administered intravenously 30 minutes after GHB ingestion. Blood and urine were collected for 6 hours, analyzed for GHB, and pharmacokinetic and statistical analyses performed. RESULTS: L-lactate/mannitol administration significantly increased GHB renal clearance compared to GHB alone, 439 vs. 615 mL/hr (P=0.001), and increased the percentage of GHB dose excreted in the urine, 2.2 vs. 3.3% (P=0.021). Total clearance was unchanged. CONCLUSIONS: MCT inhibition with L-lactate combined with osmotic diuresis increases GHB renal elimination in humans. No effect on total clearance was observed in this study due to the negligible contribution of renal clearance to total clearance at this low GHB dose. Considering the nonlinear renal elimination of GHB, further research in overdose cases is warranted to assess the efficacy of this treatment strategy for increasing renal and total clearance at high GHB doses.

Reliability of the Lifetime Inventory of Drug Use Consequences (INDUC) in methadone maintenance patients.

One hundred twenty one opiate-dependent individuals in methadone maintenance treatment at an urban university medical center in the U.S. were administered the Inventory of Drug Use Consequences (InDUC), and 68 subjects provided follow-up assessments at two to six weeks. The sample included 61 (50.4%) women; 86 (71.1%) of the subjects reported that they were White, 29 (24.0%) Black, and six (5.0%) other race. The mean age was 41.9 (SD = 9.7) years. Ninety-nine (81.8%) of participants had used opiates intravenously. INDUC total scores and a short form showed high internal consistency (alpha) and test-retest reliability (ICC) across gender, race, ethnicity, and education, supporting their use as global measures of drug use consequences. The interpersonal scale was also reliable across strata whereas the physical and intrapersonal scales were not reliable. The impulse control and social responsibility scales were stable but not internally consistent.

Outcomes with the ARISE approach to engaging reluctant drug- and alcohol-dependent individuals in treatment.

Our goal was to explore, through a Stage I NIH clinical study, the effectiveness of a manual-driven, timely response method for helping the "concerned other" get resistant substance abusers into treatment/self-help with minimum professional time/effort. A manual-driven protocol, "A Relational Sequence for Engagement (ARISE)," was applied with 110 consecutive, initial calls/contacts from concerned others; no cases excluded for research, refusal, or other reasons. The research was conducted at two upstate New York outpatient drug/alcohol clinics. Participants were concerned others who called regarding a cocaine, alcohol, or "other drug" abuser (N = 110); participating family/friends: 11 ARISE clinicians; and 110 substance abusers. ARISE is a graduated continuum starting with the least demanding option/stage, increasing effort as needed to engage substance abusers in treatment/self-help. Stage I: Coaching the concerned other to arrange a meeting of significant others, inviting the substance abuser; Stage II: 1 to 5 additional meetings (median = 2); Stage III: A modified Johnson "Intervention." Primary outcome variables were substance abuser engagement (or not) in treatment/self-help; days between first call and engagement; clinician time/effort. Predictors were concerned other, substance abuser, and clinician demographics; number of participants per case; and Collateral Addiction Severity Index. ARISE resulted in an 83% success rate (55% at Stage I). Median days to engagement was 7 (IQR = 2 to 14). Average total time (telephone, sessions) per case was 1.5 hours. Treatment/self-help chosen was 95% treatment and 5% self-help. Number of family/ friends involved correlated 0.69 with a success/efficiency index. Conclusions. A call from a family member or concerned other for help in getting a loved one into treatment is a rich opportunity for treatment professionals and agencies to engage substance abusers in treatment. These initial calls are similar to referral calls from EAPs or probation officers looking to get an individual started in treatment. ARISE provides an effective, swift, and cost-efficient option for engaging substance abusers in treatment or self-help. The more significant others involved, the greater the success of treatment engagement.