Cocaine DependencePhase 2NCT02080832
Brain Function and Structure in Cocaine Dependence
A Phase 2 study testing Citalopram in people with Cocaine Dependence, run by Virginia Commonwealth University at 1 site in United States.
Trial summary
The purpose of this study is to examine the role of brain MRI findings in predicting treatment outcomes among individuals with cocaine dependence. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Cocaine Dependence
- What is being tested?
- Citalopram
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2010to Feb 2016
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male and female subjects age 18 to 50 who meet current DSM-IV criteria for cocaine dependence who are seeking treatment.
Who cannot join
- Current DSM-IV diagnosis of any psychoactive substance dependence other than cocaine, marijuana, nicotine, or alcohol
- Have a DSM-IV axis I psychiatric disorder or neurological disease or disorder requiring ongoing treatment and/or making study participation unsafe
- Significant current suicidal or homicidal ideation
- Medical conditions contraindicating citalopram pharmacotherapy (liver disease, seizure disorder, bleeding disorder, or prolonged QT interval on EKG)
- Taking CNS active concomitant medications
- Taking medications known to have significant drug interactions with the study medication
Show all 15Show fewer
- Having conditions of probation or parole requiring reports of drug use to officers of the court
- Impending incarceration
- Pregnant or breast feeding for female patients
- Inability to read, write, or speak English
- Having plans to leave the immediate geographical area within 3 months
- Unwillingness or not competent to sign a written informed consent form
- Individuals who have pacemakers, metal or electromechanical implants or metallic foreign bodies
- Patients who are known to be HIV positive will not be included due to possible CNS effects of HIV.
- Alcohol withdrawal symptoms or history of significant previous alcohol withdrawal symptoms.
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
The purpose of this study is to examine the role of brain MRI findings in predicting treatment outcomes among individuals with cocaine dependence.
Read the detailed description
The Specific Aims of this project are:
Aim 1: To determine whether pretreatment brain activation on fMRI while performing a Go-Nogo task predicts response to pharmacotherapy in cocaine dependent subjects.
Hypothesis related to Aim 1:
Pretreatment fMRI BOLD activation in cocaine dependent subjects during impulsive responding on the Go-Nogo task predicts 8-week outcome from medication known to enhance serotonin function (citalopram). The regression coefficient of TES on pretreatment mean BOLD activation on the Go-Nogo task will be significantly greater for the citalopram group than the placebo group.
Aim 2: To determine whether pretreatment brain activation on fMRI while performing an attentional bias (cocaine Stroop) task predicts response to pharmacotherapy in cocaine dependent subjects.
Hypothesis related to Aim 2:
Pretreatment fMRI BOLD activation in cocaine dependent subjects during cocaine related words on the cocaine Stroop task predicts 8-week outcome from medication known to enhance serotonin function (citalopram). The regression coefficient of TES on pretreatment mean BOLD activation from the cocaine Stroop task will be significantly greater for the citalopram group than the placebo group.
- Conditions
- Cocaine Dependence
- Being tested
- Citalopram, Placebo
- Keywords
- substance abuse, cocaine, impulsivity, serotonin, MRI
- Medical subject headings
- Cocaine-Related Disorders, Substance-Related Disorders, Impulsive Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CitalopramDrug
Also called Celexa, Citalopram HBr
20 mg or 40 mg daily for 8 weeks
PlaceboDrug
Placebo daily for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Medication (Citalopram 20mg) | Experimental | Citalopram (20mg dose) Receives: Drug: Citalopram |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Medication (Citalopram 40mg) | Experimental | Citalopram 40mg dose Receives: Drug: Citalopram |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cocaine Use/Treatment Effectiveness Score (TES)
Number of benzoylecgonine negative urines divided by the total number of urines collected
Measured: 8 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2014 (estimated)
- Study startFeb 2010
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cocaine DependenceStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Collaborators
- The University of Texas Health Science Center, Houston, National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Frederick G Moeller, M.D., Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02080832
- Sponsor's protocol ID
- HM15378
- Other IDs
- 2P50DA009262-16A1
- Status last verified
- Nov 2017
- First submitted
- 4 Mar 2014
- Last updated
- 26 Dec 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Function and Structure in Cocaine Dependence
- ClinicalTrials.gov ID
- NCT02080832
- Acronym / sponsor ID
- HM15378
- Conditions
- Cocaine Dependence
- Keywords
- substance abuse, cocaine, impulsivity, serotonin, MRI
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- The University of Texas Health Science Center, Houston, National Institute on Drug Abuse (NIDA)
- Study start
- Feb 2010 (actual)
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 6 Mar 2014 (estimated)
- Results
- Posted 26 Dec 2017
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 examine the role of brain MRI findings in predicting treatment outcomes among individuals with cocaine dependence.
Detailed description
The Specific Aims of this project are:
Aim 1: To determine whether pretreatment brain activation on fMRI while performing a Go-Nogo task predicts response to pharmacotherapy in cocaine dependent subjects.
Hypothesis related to Aim 1:
Pretreatment fMRI BOLD activation in cocaine dependent subjects during impulsive responding on the Go-Nogo task predicts 8-week outcome from medication known to enhance serotonin function (citalopram). The regression coefficient of TES on pretreatment mean BOLD activation on the Go-Nogo task will be significantly greater for the citalopram group than the placebo group.
Aim 2: To determine whether pretreatment brain activation on fMRI while performing an attentional bias (cocaine Stroop) task predicts response to pharmacotherapy in cocaine dependent subjects.
Hypothesis related to Aim 2:
Pretreatment fMRI BOLD activation in cocaine dependent subjects during cocaine related words on the cocaine Stroop task predicts 8-week outcome from medication known to enhance serotonin function (citalopram). The regression coefficient of TES on pretreatment mean BOLD activation from the cocaine Stroop task will be significantly greater for the citalopram group than the placebo group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Medication (Citalopram 20mg) | Experimental | Drug: CitalopramCitalopram (20mg dose) |
| Placebo | Placebo comparator | Drug: Placebo |
| Medication (Citalopram 40mg) | Experimental | Drug: CitalopramCitalopram 40mg dose |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Male and female subjects age 18 to 50 who meet current DSM-IV criteria for cocaine dependence who are seeking treatment.
Key exclusion criteria (15 listed)
- Current DSM-IV diagnosis of any psychoactive substance dependence other than cocaine, marijuana, nicotine, or alcohol
- Have a DSM-IV axis I psychiatric disorder or neurological disease or disorder requiring ongoing treatment and/or making study participation unsafe
- Significant current suicidal or homicidal ideation
- Medical conditions contraindicating citalopram pharmacotherapy (liver disease, seizure disorder, bleeding disorder, or prolonged QT interval on EKG)
- Taking CNS active concomitant medications
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 |
|---|---|---|
| CitalopramAlso: Celexa, Citalopram HBr20 mg or 40 mg daily for 8 weeks | Drug | Medication (Citalopram 20mg), Medication (Citalopram 40mg) |
| PlaceboPlacebo daily for 8 weeks | Drug | Placebo |
Primary outcome
Cocaine Use/Treatment Effectiveness Score (TES)
Time frame: 8 weeks of treatment
Number of benzoylecgonine negative urines divided by the total number of urines collected
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Frederick G Moeller, M.D. principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Citalopram in people with Cocaine Dependence, run by Virginia Commonwealth University 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 1 inclusion and 15 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 26 Dec 2017. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Dec 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Cocaine Use/Treatment Effectiveness Score (TES) (time frame: 8 weeks of treatment). 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 26 Dec 2017.