Augmentation of Brief Habit Reversal Training With D-cycloserine or Placebo

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Brief Title

Augmentation of Brief Habit Reversal Training With D-cycloserine or Placebo

Official Title

Augmentation of Brief Habit Reversal Training With D-cycloserine or Placebo

Brief 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.
    

Detailed Description

      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.
    


Study Type

Interventional


Primary Outcome

Hopkins Motor/Vocal Tic Scale (HM/VTS)


Condition

Tourette Disorder

Intervention

D-cycloserine

Study Arms / Comparison Groups

 D-cycloserine + Habit Reversal Training
Description:  Participants randomly assigned to the D-cycloserine (DCS) condition will receive a single dose of DCS immediately prior to a single session of habit reversal training.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

20

Start Date

October 2015

Completion Date

August 2017

Primary Completion Date

August 2017

Eligibility Criteria

        Inclusion Criteria:

          1. ages 8 years to 17 years (inclusive);

          2. meet diagnostic criteria for either Tourette Disorder or a Persistent Tic Disorder;

          3. moderate tic severity or greater as evidenced by a Yale Global Tic Severity Scale
             (Leckman, Riddle, Hardin, & Ort, 1989) total score greater than 13 (>9 for children
             with motor or vocal tics only);

          4. be fluent in English;

          5. be medication free or on a stable dose of a non-antipsychotic medication for 6 weeks
             with no planned changes.

        Exclusion Criteria:

          1. pregnant or breast feeding;

          2. an unstable medical condition (e.g., a seizure disorder, kidney or liver disease);

          3. current diagnosis of substance abuse/dependence;

          4. lifetime diagnosis of schizophrenia, autism spectrum disorder, bipolar disorder, or
             psychosis;

          5. evidence of a seizure disorder, kidney or liver disease, pregnant and/or breast
             feeding;

          6. four or more previous sessions of HRT; or

          7. currently taking an antipsychotic medication.
      

Gender

All

Ages

8 Years - 17 Years

Accepts Healthy Volunteers

No

Contacts

Joseph F McGuire, Ph.D., , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT02582515

Organization ID

UCLA_DCS+HRT


Responsible Party

Principal Investigator

Study Sponsor

University of California, Los Angeles


Study Sponsor

Joseph F McGuire, Ph.D., Principal Investigator, University of California, Los Angeles


Verification Date

April 2019