Modafinil - Escitalopram Study for Cocaine Dependence

NCT01601730 | Completed Phase 1 DMC

• 3 other identifiers: H-256691RC1DA028387DPMC
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cocaine Dependence; Cocaine Abuse; Cocaine Addiction; Substance Abuse

Keywords

Cocaine; Modafinil; Escitalopram

Outcome Measures

Primary Outcomes (1)

• The effects of modafinil and/or escitalopram and cocaine on cardiovascular measures

  Before and after each cocaine infusion, physiologic responses will be closely monitored using repeated HR, BP, and ECG readings. To evaluate safety, a DSMB will meet annually and following any serious AE to examine data as well as any new published information on modafinil and/or escitalopram relevant to the project. The number of AEs (including arrhythmias and ECG changes), changes in BP and HR, changes in cocaine PKs, and changes in mood and psychiatric symptoms (using the BSI, BDI, POMS, and BPRS) will also be assessed throughout the study.

Secondary Outcomes (2)

• The effects of modafinil and/or escitalopram and cocaine on subjective measures

• The effects of modafinil and/or escitalopram on reinforcing effects produced by cocaine

Study Arms (4)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Modafinil 200 mg + Escitalopram 20 mg

ACTIVE COMPARATOR

Drug: Modafinil and Escitalopram

Modafinil 200 mg

ACTIVE COMPARATOR

Drug: Modafinil

Escitalopram 20 mg

ACTIVE COMPARATOR

Drug: Escitalopram

Interventions

Modafinil and Escitalopram DRUG

Treatment 4: Modafinil 200 mg + Escitalopram 20 mg

Also known as: Provigil, Lexapro

Modafinil 200 mg + Escitalopram 20 mg

Placebo DRUG

Matching oral placebo capsules as control (Treatment 1: Modafinil 0 + Escitalopram 0).

Also known as: Sugar pill

Placebo

Modafinil DRUG

Treatment 2: Modafinil 200 mg + Escitalopram 0.

Also known as: Provigil

Modafinil 200 mg

Escitalopram DRUG

Treatment 3: Modafinil 0 + Escitalopram 20 mg.

Also known as: Lexapro

Escitalopram 20 mg

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Be a cocaine-dependent volunteer who is non-treatment-seeking.
• Meet DSM-IV criteria for cocaine dependence as determined by SCID or MINI, and has provided at least one cocaine-positive urine specimen within the 2 weeks prior to enrollment.
• Be male or female, between 18 - 55 years old.
• Be able to verbalize understanding of consent form, able to provide written informed consent, and verbalize willingness to complete study procedures.
• Female subjects must be non-nursing and postmenopausal, have had a hysterectomy, undergone tubal ligation, or have a negative pregnancy test and agree to use birth control.
• Has medical history, physical exam, and screening laboratory results that demonstrate no contraindication to participation.
• Be experienced with smoking or i.v. use as a route of cocaine administration.

You may not qualify if:

• Has a history of a medical adverse reaction to cocaine or other psychostimulants, including loss of consciousness, chest pain, cardiac ischemia, or seizure.
• Has a current psychiatric disorder other than cocaine abuse or dependence (e.g., major depression, bipolar disorder, schizoaffective disorder, schizophrenia).
• Meets DSM-IV criteria for dependence on other illicit drugs (e.g., methamphetamine, heroin).
• Has received opiate-substitution therapy within 2 months of enrollment.
• Has a current or past history of seizure disorder, including alcohol- or psychostimulant- related seizures, febrile seizures, or family history of seizure disorder.
• Has a diagnosis of adult asthma, or chronic obstructive pulmonary disease, including a history of acute asthma within the past two years, and those with current or recent (with the past two years) treatment with an inhaled or oral b-adrenergic agonist.
• Has had head trauma that resulted in neurological sequelae (e.g., loss of memory for greater than 5 min or that required hospitalization).
• Has an unstable medical condition, which, in the judgment of investigators, would make participation hazardous, including, but not limited to, AIDS, acute hepatitis, active TB, unstable cardiac disease, unstable diabetes, hepatic or renal insufficiency (serum bilirubin or creatinine exceeding 1.5 the upper limit of normal, respectively).
• Be pregnant or lactating (nursing), or a fertile woman not practicing adequate methods of contraception or planning to become pregnant within one month of conclusion of the study.
• Has a history of suicide attempts within the past year and/or current suicidal ideation/plan.
• Has clinically significant ECG abnormalities, including QTc interval prolongation \>450 ms in men or \>480 ms in women.
• In the opinion of the PI, be expected to fail to complete the study protocol due to probable incarceration or relocation from the clinic area.
• Has clinically significant laboratory values (outside of normal limits), in the judgment of the PI.
• Is currently taking SSRIs, monoamine oxidase inhibitors or pimozide.

Sponsors & Collaborators

• Baylor College of Medicine: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Michael E. DeBakey VA Medical Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Cocaine-Related Disorders; Substance-Related Disorders

Interventions

Modafinil; Escitalopram; Sugars

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Propylamines; Amines; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Carbohydrates

Study Officials

• Richard De La Garza, Ph.D.

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 10, 2009
• First Posted: May 18, 2012
• Study Start: August 1, 2010
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: May 18, 2012

Record last verified: 2012-05

Locations

US (1)