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Sponsored by: |
University of Texas Southwestern Medical Center |
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Information provided by: | University of Texas Southwestern Medical Center |
ClinicalTrials.gov Identifier: | NCT00280293 |
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 |
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 |
Estimated Enrollment: | 120 |
Study Start Date: | March 2006 |
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.
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Sharon M Sowell, B.A. | 214-645-6962 | Sharon.Sowell@UTSouthwestern.edu |
Contact: Katie Gowen | 214-645-6960 | Katie.Gowen@UTSouthwestern.edu |
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 |
Principal Investigator: | E. Sherwood Brown, M.D., Ph.D. | UT Southwestern Medical Center at Dallas |
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 |
Bipolar Disorder Cocaine Dependence Dual Diagnosis |
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 |
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 |