Cocaine DependencePhase 2NCT00297505
Serotonin, Impulsivity, and Cocaine Dependence Treatment
A Phase 2 study testing citalopram in people with Cocaine Dependence, run by National Institute on Drug Abuse (NIDA) at 1 site in United States.
Trial summary
The purpose of this study is to compare the effects of citalopram versus placebo given in the context of contingency management for 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
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2001to Nov 2004
- Phase
- Phase 2
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- male and female subjects age 18 to 50 who currently meet DSM-IV criteria for cocaine dependence.
- female subjects: a negative pregnancy test
Who cannot join
- current or past DSM-IV Axis I disorder other than substance abuse/dependence
- any serious non-psychiatric medical illness requiring ongoing medical treatment
- substance dependence other than cocaine within the last 3 months
- negative urine drug screen for cocaine at time of testing
- for female subjects: a positive pregnancy test
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas - Houston Health Science Center
Houston, Texas, 77030
About this study
The purpose of this study is to compare the effects of citalopram versus placebo given in the context of contingency management for cocaine dependence.
Read the detailed description
Cocaine dependence continues to be a significant public health problem, for which there is no FDA approved pharmacotherapy. This study is a 12-week, double blind, placebo controlled trial of citalopram for cocaine dependence. The primary outcome measure is benzoylecgonine positive urines. Secondary measures of side effects and craving are also examined.
- Conditions
- Cocaine Dependence
- Being tested
- citalopram
- Keywords
- Cocaine; citalopram; impulsivity; serotonin
- Medical subject headings
- Cocaine-Related Disorders, Impulsive Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
citalopramDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
The presence of cocaine metabolites in urine weekly.
Secondary outcomes (1)
Retention rate and cocaine cravings weekly.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2006 (estimated)
- Study startApr 2001
- Study completionNov 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Enrolment
- 120 participants
Sponsor and investigators
- Lead sponsor
- National Institute on Drug Abuse (NIDA)
- Sponsor type
- US National Institutes of Health
- Investigators
- Frederick G Moeller, M.D., Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00297505
- Sponsor's protocol ID
- R01DA008425
- Status last verified
- Feb 2006
- First submitted
- 27 Feb 2006
- Last updated
- 12 Jan 2017
- Results posted
- No
Publications
Moeller FG, Schmitz JM, Steinberg JL, Green CM, Reist C, Lai LY, Swann AC, Grabowski J. Citalopram combined with behavioral therapy reduces cocaine use: a double-blind, placebo-controlled trial. Am J Drug Alcohol Abuse. 2007;33(3):367-78. doi: 10.1080/00952990701313686.
PubMed 17613964
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serotonin, Impulsivity, and Cocaine Dependence Treatment
- ClinicalTrials.gov ID
- NCT00297505
- Acronym / sponsor ID
- R01DA008425
- Conditions
- Cocaine Dependence
- Keywords
- Cocaine; citalopram; impulsivity; serotonin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants
- Lead sponsor
- National Institute on Drug Abuse (NIDA)US National Institutes of Health
- Study start
- Apr 2001
- Study completion
- Nov 2004
- First posted
- 28 Feb 2006 (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 compare the effects of citalopram versus placebo given in the context of contingency management for cocaine dependence.
Detailed description
Cocaine dependence continues to be a significant public health problem, for which there is no FDA approved pharmacotherapy. This study is a 12-week, double blind, placebo controlled trial of citalopram for cocaine dependence. The primary outcome measure is benzoylecgonine positive urines. Secondary measures of side effects and craving are also examined.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- male and female subjects age 18 to 50 who currently meet DSM-IV criteria for cocaine dependence.
- female subjects: a negative pregnancy test
Key exclusion criteria (5 listed)
- current or past DSM-IV Axis I disorder other than substance abuse/dependence
- any serious non-psychiatric medical illness requiring ongoing medical treatment
- substance dependence other than cocaine within the last 3 months
- negative urine drug screen for cocaine at time of testing
- for female subjects: a positive pregnancy test
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 |
|---|---|---|
| citalopram | Drug | – |
Primary outcome
The presence of cocaine metabolites in urine weekly.
1 secondary outcome
Retention rate and cocaine cravings weekly.
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 12 Jan 2017.
- Derived from this study: PubMed 17613964Moeller FG, Schmitz JM, Steinberg JL, Green CM, Reist C, Lai LY, Swann AC, Grabowski J. Citalopram combined with behavioral therapy reduces cocaine use: a double-blind, placebo-controlled trial. Am J Drug Alcohol Abuse. 2007;33(3):367-78. doi: 10.1080/00952990701313686.
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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
The University of Texas Health Science Center, Houston
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 National Institute on Drug Abuse (NIDA) 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 2 inclusion and 5 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 12 Jan 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. 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?
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 presence of cocaine metabolites in urine weekly.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00297505, which also lists 1 linked publication.
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 12 Jan 2017; AzTrials last refreshed its copy on 6 Nov 2026.