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

Eugenia Oviedo-Joekes, Kirsten Marchand, Kurt Lock, Scott MacDonald, Daphne Guh, Martin T Schechter, Eugenia Oviedo-Joekes, Kirsten Marchand, Kurt Lock, Scott MacDonald, Daphne Guh, Martin T Schechter

Abstract

Background: The 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.

Methods: SALOME 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.

Results: A 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).

Conclusions: As 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 registration: ClinicalTrials.gov: NCT01447212.

Figures

Figure 1
Figure 1
Cumulative recruitment, screening and enrolment to the SALOME trial. a) Cumulative recruitment into the SALOME trial. Number of applicants, ineligibles, and participants randomized to the SALOME trial over time. b) Cumulative screening of candidates in the SALOME trial. Number of candidates and randomized participants screened for the SALOME trial over time.
Figure 2
Figure 2
SALOME screening flow chart. Stages of screening in the SALOME trial and number of applicants at each stage.

References

    1. De Jong CA, Roozen HG, van Rossum LG, Krabbe PF, Kerkhof AJ. High abstinence rates in heroin addicts by a new comprehensive treatment approach. Am J Addict. 2007;16:124–130. doi: 10.1080/10550490601184472.
    1. Mattick RP, Breen C, Kimber J, Davoli M. Methadone maintenance therapy versus no opioid replacement therapy for opioid dependence. Cochrane Database Syst Rev. 2009;3:CD002209.
    1. Van den Brink W, Haasen C. Evidenced-based treatment of opioid-dependent patients. Can J Psychiatry. 2006;51:635–646.
    1. Ferri M, Davoli M, Perucci CA. Heroin maintenance for chronic heroin-dependent individuals. Cochrane Database Syst Rev. 2011;8:CD003410.
    1. Oviedo-Joekes E, Guh D, Brissette S, Marsh DC, Nosyk B, Krausz M, Anis A, Schechter MT. Double-blind injectable hydromorphone versus diacetylmorphine for the treatment of opioid dependence: A pilot study. J Subst Abuse Treat. 2010;38:408–411. doi: 10.1016/j.jsat.2010.03.003.
    1. Gates S, Brocklehurst P, Campbell M, Elbourne D. Recruitment to multicentre trials. BJOG: An International Journal of Obstetrics & Gynaecology. 2004;111:3–5. doi: 10.1111/j.1471-0528.2004.00011.x.
    1. McDonald AM, Knight RC, Campbell MK, Entwistle VA, Grant AM, Cook JA, Elbourne DR, Francis D, Garcia J, Roberts I, Snowdon C. What influences recruitment to randomised controlled trials? A review of trials funded by two UK funding agencies. Trials. 2006;7:9. doi: 10.1186/1745-6215-7-9.
    1. Treweek S, Pitkethly M, Cook J, Kjeldstrom M, Taskila T, Johansen M, Sullivan F, Wilson S, Jackson C, Jones R, Mitchell E. Strategies to improve recruitment to randomised controlled trials. Cochrane Database Syst Rev. 2010;4:Mr000013.
    1. Sully BG, Julious SA, Nicholl J. A reinvestigation of recruitment to randomised, controlled, multicenter trials: a review of trials funded by two UK funding agencies. Trials. 2013;14:166. doi: 10.1186/1745-6215-14-166.
    1. Campbell MK, Snowdon C, Francis D, Elbourne D, McDonald AM, Knight R, Entwistle V, Garcia J, Roberts I, Grant A. Recruitment to randomised trials: strategies for trial enrollment and participation study. The STEPS study. Health Technol Assess. 2007;11:ii. doi: 10.3310/hta11480.
    1. Humphreys K, Maisel NC, Blodgett JC, Finney JW. Representativeness of patients enrolled in influential clinical trials: a comparison of substance dependence with other medical disorders. J Stud Alcohol Drugs. 2013;74:889–893.
    1. Mullins CD, Vandigo J, Zheng Z, Wicks P. Patient-Centeredness in the Design of Clinical Trials. 2014;17:471–475.
    1. Points to Consider about Recruitment and Retention While Preparing a Clinical Research Study []
    1. Thomson CL, Morley KC, Teesson M, Sannibale C, Haber PS. Issues with recruitment to randomised controlled trials in the drug and alcohol field: a literature review and Australian case study. Drug Alcohol Rev. 2008;27:115–122. doi: 10.1080/09595230701829561.
    1. Ashery RS, McAuliffe WE. Implementation issues and techniques in randomized trials of outpatient psychosocial treatments for drug abusers: recruitment of subjects. Am J Drug Alcohol Abuse. 1992;18:305–329. doi: 10.3109/00952999209026069.
    1. Blanken P, van den Brink W, Hendriks VM, Huijsman IA, Klous MG, Rook EJ, Wakelin JS, Barendrecht C, Beijnen JH, van Ree JM. Heroin-assisted treatment in the Netherlands: History, findings, and international context. Eur Neuropsychopharmacol. 2010;20(Suppl 2):S105–S158. doi: 10.1016/S0924-977X(10)70001-8.
    1. March JC, Oviedo-Joekes E, Romero M, Gomez M, Rodriguez S, Leon MI, Rodriguez C, Equipo P. [The experimental drug prescription program in Andalusia [PEPSA]: procedure for recruiting participants] Gac Sanit. 2004;18:245–247. doi: 10.1157/13063102.
    1. Watson JM, Torgerson DJ. Increasing recruitment to randomised trials: a review of randomised controlled trials. BMC Med Res Methodol. 2006;6:34. doi: 10.1186/1471-2288-6-34.
    1. Demaret I, Litran G, Magoga C, Deblire C, Dupont A, De Roubaix J, Lemaître A, Ansseau M. Why do heroin users refuse to participate in a heroin-assisted treatment trial? Heroin Addiction and Related Clinical Problems. 2014;xxx:5–12.
    1. March JC, Oviedo-Joekes E, Perea-Milla E, Carrasco F. Controlled trial of prescribed heroin in the treatment of opioid addiction. J Subst Abuse Treat. 2006;31:203–211. doi: 10.1016/j.jsat.2006.04.007.
    1. Chettiar J, Lock K, Oviedo-Joekes E, Sievewright K, Schechter MT. 19th International Harm Reduction Conference, Barcelona, Spain. 2008. The recruitment of participants to the Canadian heroin trial: Free heroin is not enough.
    1. Bond Sutton L, Erlen JA, Glad JM, Siminoff LA. Recruiting vulnerable populations for research: revisiting the ethical issues. J Prof Nurs. 2003;19:106–112. doi: 10.1053/jpnu.2003.16.
    1. Barratt MJ, Norman JS, Fry CL. Positive and negative aspects of participation in illicit drug research: implications for recruitment and ethical conduct. Int J Drug Policy. 2007;18:235–238. doi: 10.1016/j.drugpo.2006.07.001.

Source: PubMed

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