Full Text View
Tabular View
No Study Results Posted
Related Studies
Lamotrigine Add-on Therapy for Bipolar Disorder and Cocaine Dependency
This study is currently recruiting participants.
Verified by University of Texas Southwestern Medical Center, August 2006
First Received: January 19, 2006   Last Updated: August 31, 2006   History of Changes
Sponsored by: University of Texas Southwestern Medical Center
Information provided by: University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT00280293
  Purpose

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.


Condition Intervention Phase
Bipolar Disorder
Cocaine Dependence
Drug: Lamotrigine
Phase IV

MedlinePlus related topics: Bipolar Disorder Depression
Drug Information available for: Cocaine hydrochloride Lamotrigine
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
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

Further study details as provided by University of Texas Southwestern Medical Center:

Primary Outcome Measures:
  • Timeline Followback
  • Cocaine Craving Questionnaire
  • Urine drug screens
  • Hamilton Rating Scale for Depression
  • Quick Inventory of Depressive Symptomatology-SR
  • Young Mania Rating Scale
  • Barratt Impulsiveness Scale
  • Rey Auditory Verbal Learning Test
  • STROOP color-word task
  • The Addiction Severity Index
  • PRD-III Somatic Symptom Scale

Estimated Enrollment: 120
Study Start Date: March 2006
Detailed Description:

One hundred and twenty (120) adult outpatients with bipolar I, II, NOS, 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 DSM-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 PRD-III Somatic Symptom Scale 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 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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of bipolar I, II, NOS 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 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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00280293

Contacts
Contact: Sharon M Sowell, B.A. 214-645-6962 Sharon.Sowell@UTSouthwestern.edu
Contact: Katie Gowen 214-645-6960 Katie.Gowen@UTSouthwestern.edu

Locations
United States, Texas
UT Southwestern Medical Center at Dallas Recruiting
Dallas, Texas, United States, 75390-8849
Contact: E. Sherwood Brown, M.D., Ph.D.     214-645-6950     Sherwood.Brown@UTSouthwestern.edu    
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
Principal Investigator: E. Sherwood Brown, M.D., Ph.D. UT Southwestern Medical Center at Dallas
  More Information

Additional Information:
No publications provided

Study ID Numbers: 05T-704
Study First Received: January 19, 2006
Last Updated: August 31, 2006
ClinicalTrials.gov Identifier: NCT00280293     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Texas Southwestern Medical Center:
Bipolar Disorder
Cocaine Dependence
Dual Diagnosis

Study placed in the following topic categories:
Dopamine Uptake Inhibitors
Cocaine-Related Disorders
Neurotransmitter Agents
Depression
Bipolar Disorder
Calcium Channel Blockers
Central Nervous System Depressants
Anesthetics
Disorders of Environmental Origin
Cardiovascular Agents
Anesthetics, Local
Calcium, Dietary
Affective Disorders, Psychotic
Dopamine
Mental Disorders
Mood Disorders
Substance-Related Disorders
Lamotrigine
Vasoconstrictor Agents
Dopamine Agents
Psychotic Disorders
Peripheral Nervous System Agents
Cocaine
Anticonvulsants

Additional relevant MeSH terms:
Dopamine Uptake Inhibitors
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Calcium Channel Blockers
Disorders of Environmental Origin
Anesthetics
Membrane Transport Modulators
Affective Disorders, Psychotic
Pathologic Processes
Mental Disorders
Sensory System Agents
Therapeutic Uses
Vasoconstrictor Agents
Substance-Related Disorders
Cocaine
Cocaine-Related Disorders
Disease
Bipolar Disorder
Central Nervous System Depressants
Cardiovascular Agents
Pharmacologic Actions
Anesthetics, Local
Lamotrigine
Mood Disorders
Dopamine Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Anticonvulsants

ClinicalTrials.gov processed this record on May 07, 2009