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Modafinil - Escitalopram Study for Cocaine Dependence

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ClinicalTrials.gov Identifier: NCT01601730
Recruitment Status : Completed
First Posted : May 18, 2012
Last Update Posted : May 18, 2012
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Richard De La Garza, Baylor College of Medicine

Tracking Information
First Submitted Date  ICMJE December 10, 2009
First Posted Date  ICMJE May 18, 2012
Last Update Posted Date May 18, 2012
Study Start Date  ICMJE August 2010
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 16, 2012)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 16, 2012)
  • The effects of modafinil and/or escitalopram and cocaine on subjective measures
    The ability of modafinil and/or escitalopram, as compared to placebo, to reduce cocaine-induced craving will be measured by VAS and ARCI.
  • The effects of modafinil and/or escitalopram on reinforcing effects produced by cocaine
    The ability of modafinil and/or escitalopram, as compared to placebo, to reduce reinforcing effects produced by cocaine will be measured by choices for cocaine vs. money in the self-administration assay.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Modafinil - Escitalopram Study for Cocaine Dependence
Official Title  ICMJE Combination Therapy With Modafinil and Escitalopram for the Treatment of Cocaine Dependence
Brief Summary The purpose of this study is to improve the efficacy of modafinil as a potential treatment for cocaine dependence.
Detailed 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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Condition  ICMJE
  • Cocaine Dependence
  • Cocaine Abuse
  • Cocaine Addiction
  • Substance Abuse
Intervention  ICMJE
  • Drug: Modafinil and Escitalopram
    Treatment 4: Modafinil 200 mg + Escitalopram 20 mg
    Other Names:
    • Provigil
    • Lexapro
  • Drug: Placebo
    Matching oral placebo capsules as control (Treatment 1: Modafinil 0 + Escitalopram 0).
    Other Name: Sugar pill
  • Drug: Modafinil
    Treatment 2: Modafinil 200 mg + Escitalopram 0.
    Other Name: Provigil
  • Drug: Escitalopram
    Treatment 3: Modafinil 0 + Escitalopram 20 mg.
    Other Name: Lexapro
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Active Comparator: Modafinil 200 mg + Escitalopram 20 mg
    Intervention: Drug: Modafinil and Escitalopram
  • Active Comparator: Modafinil 200 mg
    Intervention: Drug: Modafinil
  • Active Comparator: Escitalopram 20 mg
    Intervention: Drug: Escitalopram
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 16, 2012)
68
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2011
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Be a cocaine-dependent volunteer who is non-treatment-seeking.
  2. 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.
  3. Be male or female, between 18 - 55 years old.
  4. Be able to verbalize understanding of consent form, able to provide written informed consent, and verbalize willingness to complete study procedures.
  5. 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.
  6. Has medical history, physical exam, and screening laboratory results that demonstrate no contraindication to participation.
  7. Be experienced with smoking or i.v. use as a route of cocaine administration.

Exclusion Criteria:

  1. Has a history of a medical adverse reaction to cocaine or other psychostimulants, including loss of consciousness, chest pain, cardiac ischemia, or seizure.
  2. Has a current psychiatric disorder other than cocaine abuse or dependence (e.g., major depression, bipolar disorder, schizoaffective disorder, schizophrenia).
  3. Meets DSM-IV criteria for dependence on other illicit drugs (e.g., methamphetamine, heroin).
  4. Has received opiate-substitution therapy within 2 months of enrollment.
  5. Has a current or past history of seizure disorder, including alcohol- or psychostimulant- related seizures, febrile seizures, or family history of seizure disorder.
  6. 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.
  7. Has had head trauma that resulted in neurological sequelae (e.g., loss of memory for greater than 5 min or that required hospitalization).
  8. 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).
  9. 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.
  10. Has a history of suicide attempts within the past year and/or current suicidal ideation/plan.
  11. Has clinically significant ECG abnormalities, including QTc interval prolongation >450 ms in men or >480 ms in women.
  12. 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.
  13. Has clinically significant laboratory values (outside of normal limits), in the judgment of the PI.
  14. Is currently taking SSRIs, monoamine oxidase inhibitors or pimozide.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01601730
Other Study ID Numbers  ICMJE H-25669
1RC1DA028387 ( U.S. NIH Grant/Contract )
DPMC ( Other Identifier: NIDA )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Richard De La Garza, Baylor College of Medicine
Study Sponsor  ICMJE Baylor College of Medicine
Collaborators  ICMJE National Institute on Drug Abuse (NIDA)
Investigators  ICMJE
Principal Investigator: Richard De La Garza, Ph.D. Baylor College of Medicine
PRS Account Baylor College of Medicine
Verification Date May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP