A Randomized, Double-Blind, Placebo-Controlled, Trial of Lamotrigine Therapy in Bipolar Disorder, Depressed or Mixed Phase and Cocaine Dependence

Abstract

Bipolar disorder is associated with very high rates of substance dependence. Cocaine use is particularly common. However, limited data are available on the treatment of this population. A 10-week, randomized, double-blind, placebo-controlled trial of lamotrigine was conducted in 120 outpatients with bipolar disorder, depressed or mixed mood state, and cocaine dependence. Other substance use was not exclusionary. Cocaine use was quantified weekly by urine drug screens and participant report using the timeline follow-back method. Mood was assessed with the Hamilton rating scale for depression, quick inventory of depressive symptomatology self-report, and young mania rating scale. Cocaine craving was assessed with the cocaine-craving questionnaire. Data were analyzed using a random regression analysis that used all available data from participants with at least one postbaseline assessment (n=112). Lamotrigine and placebo groups were similar demographically (age 45.1±7.3 vs 43.5±10.0 years, 41.8% vs 38.6% women). Urine drug screens (primary outcome measure) and mood symptoms were not significantly different between groups. However, dollars spent on cocaine showed a significant initial (baseline to week 1, p=0.01) and by-week (weeks 1-10, p=0.05) decrease in dollars spent on cocaine, favoring lamotrigine. Few positive trials of medications for cocaine use, other than stimulant replacement, have been reported, and none have been reported for bipolar disorder. Reduction in amount of cocaine use by self-report with lamotrigine suggests that a standard treatment for bipolar disorder may reduce cocaine use. A study limitation was weekly assessment of urine drug screens that decreased the ability to detect between-group differences.

Revisión de la eficacia de los tratamientos para el trastorno bipolar en comorbilidad con el abuso de sustancias

“…Sin embargo, la citicolina ha demostrado abordar estos síntomas además de favorecer una mayor adhesión al tratamiento 26 , aunque estos resultados no se confirman por otros grupos de trabajo 33 . En estudios con pacientes con TB de ciclación rápida donde la lamotrigina no ha resultado efectiva 27 , el tratamiento clásico con litio sí ha demostrado serlo en lo que respecta a la sintomatología psiquiátrica 33 . Estas investigaciones fundamentan sus conclusiones en la utilización de grupo control y el empleo de pruebas o instrumentos similares para medir las variables dependientes, a pesar de adolecer de muestras en ocasiones escasas y de grandes tasas de abandono.…”

The Effect of Cognitive Functioning on Treatment Attendance and Adherence in Comorbid Bipolar Disorder and Cocaine Dependence

“…Strengths in this study are a relatively large sample size (these data are from the largest trial reported of bipolar disorder and cocaine dependence (Brown et al, 2012), the clinically important dual diagnosis population, and measurement of adherence with multiple techniques (i.e., appointment attendance, pill counts, and pill bottles returned). However, limitations are also noted.…”

“…This study is a secondary analysis of data from a 10-week, randomized, double-blind, placebo-controlled trial of lamotrigine add-on therapy in outpatients with comorbid bipolar I, II, or NOS disorder (depressed or mixed phase) and cocaine dependence (Brown, Sunderajan, Hu, Sowell, & Carmody, 2012). The study was approved by the University of Texas Southwestern Medical Center Institutional Review Board.…”

“…Participants were paid for participation and transportation costs. During the time period that this research study was conducted, the form of payment between participants switched from check to cash (see Brown et al, 2012, for comprehensive details).…”

Bupropion as an Add-on Therapy in Depressed Bipolar Disorder Type I Patients With Comorbid Cocaine Dependence

“…18 Nevertheless, only a small number of studies focus on this important subpopulation of patients. [19][20][21][22] The reasons for this paucity of data might be the following: a current SUD is usually an exclusion criteria in most of the pharmacological studies on BD-I, so the available data on efficacy and safety of pharmacological treatments are few. 23 Moreover, patients with SUD often show poor compliance to treatment and have a high rate of dropouts, thus resulting in a reduced study completion.…”