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

Substance Abuse Treatment, Prevention, and Policy

Martin T Schechter²  Daphne Guh¹  Scott MacDonald³  Kurt Lock¹  Kirsten Marchand²  Eugenia Oviedo-Joekes² 

[1] Centre for Health Evaluation & Outcome Sciences, Providence Health Care, St. Paul's Hospital, 575- 1081 Burrard St., Vancouver, BC V6Z 1Y6, Canada;School of Population and Public Health, University of British Columbia, 2206 East Mall, Vancouver, BC V6T 1Z3, Canada;Providence Health Care, Providence Crosstown Clinic, 84 West Hastings Street, Vancouver, BC V6B 1G6, Canada

关键词: Randomized clinical trial;    Recruitment;    Injectable hydromorphone;    Injectable diacetylmorphine;    Opioid dependency;   

Others  :  1131518
DOI  :  10.1186/1747-597X-10-3

 received in 2014-11-28, accepted in 2015-01-17,  发布年份 2015

【 摘 要 】

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.

【 授权许可】

   
2015 Oviedo-Joekes et al.; licensee BioMed Central.

【 图 表 】

Figure 1.

Figure 2.

【 参考文献 】

• [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.
• [2]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.
• [3]Van den Brink W, Haasen C: Evidenced-based treatment of opioid-dependent patients. Can J Psychiatry 2006, 51:635-646.
• [4]Ferri M, Davoli M, Perucci CA: Heroin maintenance for chronic heroin-dependent individuals. Cochrane Database Syst Rev 2011, 8:CD003410.
• [5]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.
• [6]Gates S, Brocklehurst P, Campbell M, Elbourne D: Recruitment to multicentre trials. BJOG: An International Journal of Obstetrics & Gynaecology 2004, 111:3-5.
• [7]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. BioMed Central Full Text
• [8]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.
• [9]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. BioMed Central Full Text
• [10]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. ix-105
• [11]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.
• [12]Mullins CD, Vandigo J, Zheng Z, Wicks P: Patient-Centeredness in the Design of Clinical Trials.. 2014, 17:471-475.
• [13]Points to Consider about Recruitment and Retention While Preparing a Clinical Research Study [http://www.nimh.nih.gov/funding/grant-writing-and-application-process/recruitment-points-to-consider-6-1-05_34848.pdf webcite]
• [14]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.
• [15]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.
• [16]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.
• [17]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.
• [18]Watson JM, Torgerson DJ: Increasing recruitment to randomised trials: a review of randomised controlled trials. BMC Med Res Methodol 2006, 6:34. BioMed Central Full Text
• [19]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.
• [20]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.
• [21]Chettiar J, Lock K, Oviedo-Joekes E, Sievewright K, Schechter MT: The recruitment of participants to the Canadian heroin trial: Free heroin is not enough. 19th International Harm Reduction Conference, Barcelona, Spain 2008. Poster presentation
• [22]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.
• [23]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.