Lamotrigine add-on Therapy for Bipolar Disorder and Cocaine Dependency
Information source: University of Texas Southwestern Medical Center
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Bipolar Disorder; Cocaine Dependence
Intervention: Lamotrigine (Drug); Placebo (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: University of Texas Southwestern Medical Center Official(s) and/or principal investigator(s): E. Sherwood Brown, M.D., Ph.D., Principal Investigator, Affiliation: UT Southwestern Medical Center at Dallas
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.
Clinical Details
Official title: A Randomized, Double-blind, Placebo-controlled, Trial of Lamotrigine add-on Therapy in Outpatients With Bipolar Disorder, Depressed or Mixed Phase and Cocaine Dependence
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Days of Cocaine UsePositive Urine Drug Screens
Secondary outcome: Depression Score on the Hamilton Rating Scale For DepressionDollars Spent
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Diagnosis of bipolar I, II, not otherwise specified or cyclothymic disorders
- Currently depressed or mixed mood state
- Ages 18-70 years
- Men or women
- Self-reported cocaine use within 14 days prior to randomization
- English or Spanish speaking
- Baseline Hamilton Depression Rating Scale (HRSD17) score ≥ 10
Exclusion Criteria:
- Currently taking an enzyme inducing or inhibiting anticonvulsant (e. g. valproic acid,
carbamazepine)
- Current severe psychotic features (e. g. daily auditory hallucinations, fixed
delusions, severely disorganized thought processes) that require antipsychotic
therapy, and that do not appear to be secondary to cocaine use
- Active suicidal ideation (plan and intent) or ≥2 attempts in past 12 months or any
attempt in the past month
- Highly unstable medical condition
- Change in concomitant psychiatric medications (e. g. initiated antipsychotic) or in
other substance abuse treatment (e. g. began intensive outpatient treatment) within 7
days prior to study entry
- Vulnerable populations (e. g. pregnant or nursing women, prisoners, mentally retarded)
Locations and Contacts
UT Southwestern Medical Center at Dallas, Dallas, Texas 75390-8849, United States
Additional Information
Psychoneuroendocrinology Research Group - University of Texas Southwestern Medical Center at Dallas
Starting date: March 2006
Last updated: July 30, 2013
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