Augmentation of Brief Habit Reversal Training With D-cycloserine or Placebo
Status:
Completed
Trial end date:
2017-08-01
Target enrollment:
Participant gender:
Summary
Expert reviews and practice parameter papers recommend behavior therapy as a first-line
intervention for youth with chronic tic disorders (CTDs) with mild-to-moderate tic severity.
Although behavior therapies like the Comprehensive Behavioral Intervention for Tics (CBIT)
are efficacious in reducing tic symptom severity, only 50% of individuals exhibit a positive
treatment response. Thus, there is a clear need to identify strategies to improve treatment
response and/or accelerate therapeutic gains .
The primary ingredient of CBIT is habit reversal training (HRT), which utilizes both
extinction and associative learning. Psychosocial treatments relying on these learning
mechanisms have demonstrated an enhanced and/or expedited therapeutic benefit when augmented
with d-cycloserine (DCS). This feasibility study will examine the incremental efficacy of
HRT+DCS over HRT+placebo for tics targeted with HRT. Eligibility criteria will parallel the
child CBIT trial for generalizability and comparability, with the addition of DCS
contraindications as exclusionary criteria. Parents and youth will complete a battery of
clinical assessments to ascertain tic symptoms severity and co-occurring psychiatric
conditions. Afterwards, participants will be randomly assigned to receive either HRT+DCS or
HRT+placebo. Instead of a full course of HRT (8 sessions over 10 weeks), a more efficient
Quick-Win/Fast-Fail trial design will be used that includes a truncated HRT protocol to
provide results in a more timely fashion. As a result of this trial design, the primary
outcome of this study will focus on the reduction of bothersome tic severity for those
targeted in treatment rather than global severity reductions.