Cocaine DependencePhase 1NCT01601730
Modafinil - Escitalopram Study for Cocaine Dependence
A Phase 1 study testing Modafinil and Escitalopram, Modafinil and Escitalopram in people with Cocaine Dependence and Cocaine Abuse, run by Baylor College of Medicine at 1 site in United States.
Trial summary
The purpose of this study is to improve the efficacy of modafinil as a potential treatment for cocaine dependence. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Cocaine Dependence, Cocaine Abuse, Cocaine Addiction
- What is being tested?
- Modafinil and Escitalopram, Modafinil and Escitalopram
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2010to Jul 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Michael E. DeBakey VA Medical Center
Houston, Texas, 77030
About this study
Official title: Combination Therapy With Modafinil and Escitalopram for the Treatment of Cocaine Dependence
The purpose of this study is to improve the efficacy of modafinil as a potential treatment for cocaine dependence.
Read the 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.
- Conditions
- Cocaine Dependence, Cocaine Abuse, Cocaine Addiction, Substance Abuse
- Being tested
- Modafinil and Escitalopram, Placebo, Modafinil, Escitalopram
- Keywords
- Cocaine, Modafinil, Escitalopram
- Medical subject headings
- Cocaine-Related Disorders, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modafinil and EscitalopramDrug
Also called Provigil, Lexapro
Treatment 4: Modafinil 200 mg + Escitalopram 20 mg
PlaceboDrug
Also called Sugar pill
Matching oral placebo capsules as control (Treatment 1: Modafinil 0 + Escitalopram 0).
ModafinilDrug
Also called Provigil
Treatment 2: Modafinil 200 mg + Escitalopram 0.
EscitalopramDrug
Also called Lexapro
Treatment 3: Modafinil 0 + Escitalopram 20 mg.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Modafinil 200 mg + Escitalopram 20 mg | Active comparator | Not described Receives: Drug: Modafinil and Escitalopram |
| Modafinil 200 mg | Active comparator | Not described Receives: Drug: Modafinil |
| Escitalopram 20 mg | Active comparator | Not described Receives: Drug: Escitalopram |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2012 (estimated)
- Study startAug 2010
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cocaine DependenceStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Richard De La Garza, Baylor College of Medicine
- Investigators
- Richard De La Garza, Ph.D., Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01601730
- Sponsor's protocol ID
- H-25669
- Other IDs
- 1RC1DA028387, DPMC
- Status last verified
- May 2012
- First submitted
- 10 Dec 2009
- Last updated
- 18 May 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combination Therapy With Modafinil and Escitalopram for the Treatment of Cocaine Dependence
- ClinicalTrials.gov ID
- NCT01601730
- Acronym / sponsor ID
- H-25669
- Conditions
- Cocaine Dependence, Cocaine Abuse, Cocaine Addiction, Substance Abuse
- Keywords
- Cocaine, Modafinil, Escitalopram
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Aug 2010
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 18 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Modafinil and EscitalopramAlso: Provigil, LexaproTreatment 4: Modafinil 200 mg + Escitalopram 20 mg | Drug | Modafinil 200 mg + Escitalopram 20 mg |
| PlaceboAlso: Sugar pillMatching oral placebo capsules as control (Treatment 1: Modafinil 0 + Escitalopram 0). | Drug | Placebo |
| ModafinilAlso: ProvigilTreatment 2: Modafinil 200 mg + Escitalopram 0. | Drug | Modafinil 200 mg |
| EscitalopramAlso: LexaproTreatment 3: Modafinil 0 + Escitalopram 20 mg. | Drug | Escitalopram 20 mg |
Primary outcome
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.
2 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard De La Garza, Ph.D. principal investigator
Baylor College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Modafinil and Escitalopram, Modafinil and Escitalopram in people with Cocaine Dependence and Cocaine Abuse, run by Baylor College of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The effects of modafinil and/or escitalopram and cocaine on cardiovascular measures. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2012.