Lamotrigine add-on Therapy for Bipolar Disorder and Cocaine Dependency
Condition: Bipolar Disorder; Cocaine Dependence
MeSH terms: Cocaine-Related Disorders; Bipolar Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine if lamotrigine add-on therapy is associated with
      decreased cocaine craving and improvement in depressive symptom severity than placebo in a
      group of outpatients with bipolar disorder and cocaine dependence. Additionally, this study
      is examining whether lamotrigine add-on therapy is associated with decreased cocaine use and
      the improvement of manic symptom severity than placebo in a group of outpatients with bipolar
      disorder and cocaine dependence.
    

Detailed description: 
      One hundred and twenty (120) adult outpatients with bipolar I, II, not otherwise specified,
      or cyclothymic disorder and current cocaine dependence will be enrolled. After obtaining
      informed consent baseline assessment measures will be administered including the Structured
      Clinical Interview for Diagnostic Statistical Manual-IV Axis I Disorders. Drug use will be
      assessed using the timeline-followback method to quantify days and amount of drug use, urine
      drug screens will also be obtained and craving will be assessed with the Cocaine Craving
      Questionnaire. Mood symptoms will be quantified at each weekly visit with the Hamilton Rating
      Scale for Depression (17-item version), Quick Inventory of Depressive Symptomatology-SR
      (QIDS-SR), and Young Mania Rating Scale (YMRS). Impulsivity will be assessed at weeks 0, 5
      and 10 with the Barratt Impulsiveness Scale (BIS, Barratt et al 1983). Cognition will be
      assessed at weeks 0, 5, and 10 with the Rey Auditory Verbal Learning Test (RAVLT) and STROOP
      color-word task. The Addiction Severity Index (ASI) will be administered at baseline and week
      10. The Psychobiology of Recovery in Depression-III Somatic Symptom Scale (PRD-III)will be
      administered every 2 weeks to track side effects. A study psychiatrist will assess
      participant-reported side effects weekly. Women of childbearing age will be given a test to
      rule out pregnancy. Subjects will be randomized and Lamotrigine therapy or identical
      appearing placebo add-on therapy in a double- blind fashion will be initiated at 25 mg/day
      and increased to 200 mg/day using a slow upward titration over 5 weeks (as outlined by
      Calabrese et al 2000 and following the package insert) to minimize risk of side effects such
      as rash. After that time additional increases in 100 mg/day increments to a maximum of 400
      mg/day can be made if the medication is well tolerated and HRSD scores have decreased by ≤
      40% from baseline or Cocaine Craving Questionaire (CCQ) scores have decreased ≤ 25% from
      baseline or participants continue to use cocaine in past week based on either self-report or
      urine drug screen results. Subjects will be assessed weekly for mood and drug use/craving and
      every four weeks for cognition over 10 weeks. All of the assessments may be provided in
      Spanish, if needed. Additionally, a Spanish-speaking research assistant and study
      psychiatrist will be available at all times.

      Subjects will be paid $30 for each visit and given $2 restaurant coupons. Parking tokens ($3)
      or bus passes ($2) will also be provided. Concomitant medications will be managed with an
      algorithm that discourages but, if necessary, allows changes in other psychiatric
      medications. At the completion of 10 weeks of blinded therapy participants in both groups
      will be offered 4 weeks of open-label therapy either continuing at the week 10 dose in those
      on active medication or slowly titrated upward for those on placebo. Participants will be
      assessed with the HRSD, QIDS-SR, YMRS, CCQ and drug use quantified at biweekly appointments
      with the RAVLT and STROOP also administered at week 14 exit. Participants will not be paid
      for participation in the open-label phase but bus tokens and parking passes will be provided.
    

Intervention name(s): Lamotrigine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Lamotrigine; Placebo
Intervention MeSH terms: Lamotrigine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Bipolar Disorder; Cocaine Dependence; Dual Diagnosis