Modafinil - Escitalopram Study for Cocaine Dependence

Completed · Phase 1 · Has a placebo group

Conditions studied: Cocaine Dependence, Cocaine Abuse, Cocaine Addiction, Substance Abuse

In brief

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

Key facts

Study ID

NCT01601730

Run by

Baylor College of Medicine

People needed

68

Starts

2010-08-01

Expected to finish

2011-07-01

Last updated by the study team

2012-05-18

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Michael E. DeBakey VA Medical Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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