Lamotrigine add-on Therapy for Bipolar Disorder and Cocaine Dependency

NCT00280293 | Completed Phase 4 Results

• 1 other identifier: 05T-704
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Bipolar Disorder; Cocaine Dependence

Keywords

Bipolar Disorder; Cocaine Dependence; Dual Diagnosis

Outcome Measures

Primary Outcomes (2)

• Days of Cocaine Use

  Number of days of cocaine use during the 7 days that comprise week 10 of the protocol, by self report, or at last assessment if participant withdrew early, as assessed by the Timeline Followback method.

  10 weeks

• Positive Urine Drug Screens

  Percentage of participants with a positive urine drug screen for cocaine at the week 10 visit or at last assessment if participant withdrew early.

  10 weeks

Secondary Outcomes (2)

• Depression Score on the Hamilton Rating Scale For Depression

  10 weeks

• Dollars Spent

  10 weeks

Study Arms (2)

1

PLACEBO COMPARATOR

Placebo

Drug: Placebo

2

ACTIVE COMPARATOR

LAmotrigine

Drug: Lamotrigine

Interventions

Lamotrigine DRUG

Lamotrigine

2

Placebo DRUG

Placebo

1

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

UT Southwestern Medical Center at Dallas

Dallas, Texas, 75390-8849, United States

Location

MeSH Terms

Conditions

Bipolar Disorder; Cocaine-Related Disorders

Interventions

Lamotrigine

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Triazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Limitations and Caveats

The weekly UDS (rather than thrice weekly as is customary in cocaine trials) design feature decreased our number of observations and statistical power, and did not provide us with a complete picture of cocaine use between weekly visits.

Results Point of Contact

• Title: Dr. E. Sherwood Brown
• Organization: UT Southwestern Medical Center

sherwood.brown@utsouthwestern.edu

214-645-6950

Study Officials

• E. Sherwood Brown, M.D., Ph.D.

  UT Southwestern Medical Center at Dallas

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, MD/PhD

Study Record Dates

• First Submitted: January 19, 2006
• First Posted: January 20, 2006
• Study Start: March 1, 2006
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: September 26, 2013
• Results First Posted: September 26, 2013

Record last verified: 2013-07

Locations

US (1)