Modafinil - Escitalopram Study for Cocaine Dependence

Status Completed

Clinical Trial Summary

The purpose of this study is to improve the efficacy of modafinil as a potential treatment for cocaine dependence.

Clinical Trial Description

In this application, we propose an augmentation strategy intended to improve the efficacy of modafinil as a potential treatment for cocaine dependence. Recent data indicates that during chronic treatment modafinil produces substantial dopamine transporter (DAT) inhibition. Given that cocaine inhibits DA, norepenepherine (NE) and serotonin (5-HT) reuptake, it is highly likely that targeting more than one neurotransmitter system will be necessary for a medication to be effective. Assuming that this statement is true, we hypothesize that a combination pharmacotherapeutic approach that concurrently modulates multiple neurotransmitter systems will likely demonstrate a clinically significant level of efficacy above trials in which a single medication is used. The proposed approach is based on preclinical data indicating that medications that increase brain 5-HT levels reduce the effects of stimulants. We hypothesize that combining modafinil with a selective serotonin reuptake inhibitor (SSRI), which will increase synaptic levels of 5-HT, will further improve the efficacy of modafinil for reducing the effects produced by cocaine.

Specific Aims: 1) to determine the effects of treatment with oral modafinil (0 or 200 mg) plus the SSRI escitalopram (0 or 20 mg) on the subjective and reinforcing effects produced by intravenous cocaine (0 and 20 mg) in the laboratory. 2) to characterize the cocaine dependent population and the genetic basis for the rewarding effects produced by cocaine. 3) to characterize the effect of both modafinil treatment and cocaine exposure onBrain Derived Neurotrophic Factor (BDNF) in plasma. We hypothesize that both modafinil treatment and cocaine exposure will alter plasma levels of BDNF. 4 a) provide a more frequent measure of heart rate (15 sec vs. 5 minutes) and b) measure a new dependent variable, physical activity, on days with and without cocaine exposure. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01601730
Study type	Interventional
Source	Baylor College of Medicine
Contact
Status	Completed
Phase	Phase 1
Start date	August 2010
Completion date	July 2011

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT04070521` - EEG Monitoring in the Emergency Department
Completed	`NCT00729391` - Women-Focused HIV Prevention in the Western Cape	Phase 2/Phase 3
Active, not recruiting	`NCT03129334` - Preventing Prescription Drug Abuse in Middle School Students	N/A
Completed	`NCT02733003` - Implementation Research for Vulnerable Women in South Africa	N/A
Completed	`NCT02573948` - Feasibility of Interventions on People Who Inject Drugs in Vietnam
Completed	`NCT02282306` - Phone Interview to Prevent Recurring Opioid Overdoses	N/A
Withdrawn	`NCT01847300` - cSBI-M for Young Military Personnel	N/A
Withdrawn	`NCT01523444` - Advancing Adolescent Screening and Brief Intervention Protocols in Primary Care Settings	Phase 3
Completed	`NCT01481428` - Reducing High Risk Behavior in Treatment Court	Phase 1
Completed	`NCT01591239` - Home-Based Program to Help Parents of Drug Abusing Adolescents	N/A
Completed	`NCT01601743` - Exercise as a Behavioral Treatment for Cocaine Dependence	N/A
Active, not recruiting	`NCT00847548` - Treatment of Intimate Partner Violence and Substance Abuse in a Forensic Setting	N/A
Completed	`NCT01614015` - Building Outcomes With Observation-Based Supervision: An FFT Effectiveness Trial	Phase 2
Withdrawn	`NCT01228890` - Primary Care Internet-Based Depression Prevention for Adolescents (CATCH-IT)	Phase 3
Completed	`NCT01621334` - The Men's Domestic Abuse Check-Up Engages Adult Men Concerned About Their Abusive Behavior and Alcohol or Drug Use	Phase 1
Completed	`NCT00841711` - Transitions: Linkages From Jail To Community	N/A
Completed	`NCT00717444` - Healthy Activities for Prize Incentives	N/A
Completed	`NCT01188434` - Integrating Interventions for Maternal Substance Abuse	Phase 1
Completed	`NCT00685074` - Computer-based Brief Intervention for Perinatal Substance Abuse	Phase 1/Phase 2
Completed	`NCT01465490` - Monitoring and Feedback in Substance Abuse Treatment	Phase 1/Phase 2

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.