Harmen Beurmanjer

81 Baclofen for GHB-Dependent Patients 6 was increased to a maximum of 60mg daily. This dose was maintained for 10 weeks. In case of relapse or adverse events, immediate cessation of treatment was considered to avoid intoxication hazards. Compliance was assessed during weekly meetings between the prescribing physician and the patient Treatment as usual (TAU) All participants received TAU as provided by their addiction treatment centre, including cognitive behavioural therapy with additional treatment for social, psychiatric, and medical problems if necessary. Outcome measures Lapse and Relapse Lapse and relapse were measured by self-report on a questionnaire at three-months follow-up. Lapse was defined as any use of GHB and relapse as weekly use of GHB during the past 3 months. Patients who were no longer in care at follow-up were contacted through telephone and e-mail. Those unavailable for follow-up were considered relapsed. Side effects Safety of baclofen was monitored using a baclofen side effects questionnaire, both self-monitored and observed by treating physicians. This questionnaire was based on the side effects of baclofen reported in the literature(Kamal, Loonen, et al., 2015), containing 21 items with a five-point Likert scale (range: 0=never to 4=always). Examples are vomiting, nausea and diarrhoea. See supplementary table 1 for the complete list. Figure 1 Flowchart participants included in the study. Screened patients (n=137) Inclusion (n=107) TAU (n=70) Baclofen + TAU (n=37) Drop-out 21% (n=15) Drop-out 5% (n=2) Available at Follow-up (n=55) Available at Follow-up ITT (n=35) PP (n=12) Exclusion (n=30) No treatment n=23 Not meeting inclusion criteria n=7