The SALOME study: recruitment experiences in a clinical trial offering injectable diacetylmorphine and hydromorphone for opioid dependency

Abstract

BackgroundThe Study to Assess Long-term Opioid Medication Effectiveness (SALOME) is a two-stage phase III, single site (Vancouver, Canada), randomized, double blind controlled trial designed to test if hydromorphone is as effective as diacetylmorphine for the treatment of long-term illicit opioid injection. Recruiting participants for clinical trials continues to be a challenge in medical and addiction research, with many studies not being able to reach the planned sample size in a timely manner. The aim of this study is to describe the recruitment strategies in SALOME, which offered appealing treatments but had limited clinic capacity and no guaranteed post-trial continuation of the treatments.MethodsSALOME included chronic opioid-dependent, current illicit injection opioid users who had at least one previous episode of opioid maintenance treatment. Regulatory approvals were received in June 2011 and recruitment strategies were implemented over the next 5 months. Recruitment strategies included ongoing open communication with the community, a consistent and accessible team and participant-centered screening. All applicants completed a pre-screening checklist to assess prerequisites. Applicants meeting these prerequisites were later contacted to commence the screening process.ResultsA total of 598 applications were received over the two-year recruitment period; 130 were received on the first day of recruitment. Of these applicants, 485 met prerequisites; however, many could not be found or were not reached before recruitment ended. For the 253 candidates who initiated the screening process, the average time lapse between application and screening date was 8.3 months (standard deviation [SD] = 4.44) and for the 202 randomized to the study, the average processing time from initial screen to randomization was 25.9 days (SD = 37.48; Median = 15.0).ConclusionsAs in prior trials offering injectable diacetylmorphine within a supervised model, recruiting participants for this study took longer than planned. The recruitment challenges overcome in SALOME were due to the high number of applicants compared with the limited number that could be randomized and treated. Our study emphasizes the value of integrating these strategies into clinical addiction research to overcome study-specific barriers.Trial registrationClinicalTrials.gov: NCT01447212.

Improving recruitment to pharmacological trials for illicit opioid use: findings from a qualitative focus group study

“…For example, participants reported that study enrolment was deterred by the burden and conditions of involvement ; concerns about confidentiality ; mistrust of researchers ; and reluctance to be a treatment ‘guinea pig’ . In contrast, recruitment was encouraged by access to study information ; the presence of medical care and monitoring ; treatments being desirable ; and reimbursements or incentives .…”

“…Responding to these problems, addiction researchers have already identified strategies that can be incorporated into their RCT designs to facilitate and enhance recruitment. These include offering financial reimbursements or incentives ; providing non‐monetary incentives, such as coffee or bus tokens ; increasing the odds of receiving the experimental treatment ; simplifying the study referral processes ; providing treatments which appeal to the target population or are otherwise unavailable ; sending appointment reminders ; inviting trial participants to recruit others from their social networks ; highlighting the potential benefits of the study to patients and staff ; and engaging with peer and community organizations to secure their commitment to the research .…”

“…Difficulties recruiting participants to RCTs are common within most medical research ; indeed, one review of RCTs throughout a range of medical conditions found that nearly half received an extension due to recruitment problems . Many addiction trials have also reported problems achieving their target sample sizes or taking longer to recruit than planned . According to one review, fewer than 45 of every 100 potential participants in drug dependence RCTs were actually eligible, consented and did not drop out immediately after randomization .…”

“…In addition, recruitment to alcohol and other drug trials can be hampered because clinic staff have insufficient interest, time or capacity to conduct the research ; forget or become confused by complicated entry criteria and so do not refer patients to the trial ; and do not understand or are sceptical about the research or the trial drug . Other recruitment challenges are more practical, such as strict eligibility criteria that limit the pool of potential participants ; fewer potential participants than expected or needed in a particular area or service ; and difficulty contacting potential participants because they lack stable accommodation, move around or change telephone numbers .…”

Cost‐effectiveness of hydromorphone for severe opioid use disorder: findings from the SALOME randomized clinical trial

“…Despite this, medically prescribed DAM is not available in Canada without special access due to regulatory and political reasons . In the quest to find a more politically acceptable alternative to DAM, the Study to Assess Long‐term Opioid Maintenance Effectiveness (SALOME) trial was conducted to test if injectable hydromorphone (HDM) was non‐inferior to injectable DAM as a second‐line treatment for severe opioid use disorder . HDM is currently licensed for moderate to severe pain treatment but at smaller doses than utilized in the SALOME trial for treatment of opiate dependence.…”