Cocaine DependencePhase 2NCT01535573

Citalopram for Cocaine Dependence

A Phase 2 study testing Citalopram in people with Cocaine Dependence, run by Joy Schmitz at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 60 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: 108 participants
Where: 1 siteUnited States
Study dates: Dec 2010to Jul 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 60 years
All sexes
No healthy volunteers
Adult

Who may be able to join

between 18 and 60 years of age
meet Diagnostic and Statistical Manual 4 (DSM-IV) criteria for current cocaine dependence
be in acceptable health on the basis of interview, medical history and physical exam
able to provide the names of at least 2 persons who can generally locate their whereabouts.

Who cannot join

diagnosis of any psychoactive substance dependence other than cocaine, marijuana, or nicotine
have a psychiatric disorder or neurological disease or disorder requiring ongoing treatment and/or making study participation unsafe
medical conditions contraindicating citalopram pharmacotherapy
taking medications known to have significant drug interactions with the study medication
pregnant or nursing for female patients
having plans to leave the immediate geographical area within 3 months

Trial locations and contacts

1 site in 1 country.

United States1 site

UT-Houston Behavioral and Biomedical Sciences Building
Houston, Texas, 77054

Other trials in United States

About this study

Official title: Clinical Trial of Serotonin Medication Combination in Cocaine Dependence

This is a phase 2 clinical trial of citalopram pharmacotherapy for treatment of cocaine dependence. Using a double-blind, randomized controlled design, eligible cocaine dependent patients will be assigned equally to one of three medication conditions: placebo or the Selective serotonin re-uptake inhibitor (SSRI) agent, citalopram at either 20 mg per day or 40 mg per day. It is hypothesized that citalopram will reduce cocaine use and increase periods of sustained abstinence substantially more than placebo. Performance on a set of behavioral tasks of impulsivity will be analyzed as potential predictors of treatment response.

Conditions: Cocaine Dependence
Being tested: Citalopram, Placebo
Keywords: Cocaine, citalopram, treatment, serotonin
Medical subject headings: Cocaine-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CitalopramDrug
20 mg once per day for 9 weeks
CitalopramDrug
40 mg per day for 9 weeks
PlaceboDrug
0 mg per day for 9 weeks

Study groups in NCT01535573
Study group	Role	What they receive
Citalopram low dose	Active comparator	Citalopram 20 mg Receives: Drug: Citalopram
Citalopram high dose	Active comparator	Citalopram 40 mg Receives: Drug: Citalopram
Placebo	Placebo comparator	Placebo Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants Who Are Cocaine Abstinent During the Last 2 Weeks of Treatment (Weeks 8-9), as Assessed by Urine Test
Urine samples were tested for benzoylecgonine, which is a metabolite of cocaine that is excreted in the urine. The presence of benzoylecgonine in the urine indicates cocaine use.
Measured: 9 weeks

Secondary outcomes (3)

Proportion of Cocaine-positive Urines Per Week
Mean proportion of cocaine-positive urines per week, averaged across 9 weeks, is reported. Urine was collected three times each week over 9 weeks. Missing data is imputed as cocaine use.
Measured: 9 weeks
Number of Participants With Cocaine-negative Urines Collected During Treatment Period
Urine samples were tested for benzoylecgonine, which is a metabolite of cocaine that is excreted in the urine. The presence of benzoylecgonine in the urine indicates cocaine use.
Measured: 9 weeks
Retention as Assessed by Number of Participants Remaining in Treatment
Measured: 9 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2010Jul 2016

First posted17 Feb 2012 (estimated)
Study startDec 2010
Primary completionJul 2016
Study completionJul 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.
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: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 108 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01535573
Sponsor's protocol ID: 2P50DA009262-16A1
Other IDs: 2P50DA009262-16A1
Status last verified: Aug 2020
First submitted: 24 Oct 2011
Last updated: 16 Sep 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

de Dios C, Suchting R, Green CE, Webber HE, Moeller FG, Lane SD, Schmitz J. The role of Iowa gambling task performance in response to citalopram treatment for cocaine use disorder. Am J Drug Alcohol Abuse. 2025 Jan 2;51(1):73-84. doi: 10.1080/00952990.2024.2420773. Epub 2025 Jan 24.
PubMed 39853194

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
rTMS and Cognitive-behavioral Therapy for Cocaine Use Disorder
Cocaine Use, Cocaine Dependence
Recruiting
Transcranial Direct Current Stimulation (tDCS) for Treatment of Substance Use Disorder
Cocaine Use Disorder, Cocaine Dependence
Not yet recruiting
QAIAx (AIhealth4U) - AI Smart Health Cities: Microcity Enclave Program (Quantum AI/AGI Agency a/k/a AI City Hall Project - UPSTO App Nos. 64/074,526, 64/063,557, 64/105,164, 63/903,181, 63/729,428, 64/125,360)
Asperger's Disorder, Asperger Disorder
RecruitingPhase 1
Safety Study of a Disrupted Adenovirus (Ad) Serotype Cocaine Vaccine for Cocaine-dependent Individuals
Cocaine Dependence
Active, not recruitingPhase 1
AAV8-hCocH for Cocaine Use Disorder
Cocaine Dependence, in Remission

All Cocaine Dependence trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Trial of Serotonin Medication Combination in Cocaine Dependence
ClinicalTrials.gov ID: NCT01535573
Acronym / sponsor ID: 2P50DA009262-16A1
Conditions: Cocaine Dependence
Keywords: Cocaine, citalopram, treatment, serotonin
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 108 participants (actual)
Lead sponsor: Joy SchmitzUniversity, hospital or other
Collaborators: National Institute on Drug Abuse (NIDA)
Study start: Dec 2010
Primary completion: Jul 2016 (actual)
Study completion: Jul 2016 (actual)
First posted: 17 Feb 2012 (estimated)
Results: Posted 31 Aug 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Citalopram low dose	Active comparator	Drug: CitalopramCitalopram 20 mg
Citalopram high dose	Active comparator	Drug: CitalopramCitalopram 40 mg
Placebo	Placebo comparator	Drug: PlaceboPlacebo

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (4 listed)

between 18 and 60 years of age
meet Diagnostic and Statistical Manual 4 (DSM-IV) criteria for current cocaine dependence
be in acceptable health on the basis of interview, medical history and physical exam
able to provide the names of at least 2 persons who can generally locate their whereabouts.

Key exclusion criteria (6 listed)

diagnosis of any psychoactive substance dependence other than cocaine, marijuana, or nicotine
have a psychiatric disorder or neurological disease or disorder requiring ongoing treatment and/or making study participation unsafe
medical conditions contraindicating citalopram pharmacotherapy
taking medications known to have significant drug interactions with the study medication
pregnant or nursing for female patients

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
Citalopram20 mg once per day for 9 weeks	Drug	Citalopram low dose
Citalopram40 mg per day for 9 weeks	Drug	Citalopram high dose
Placebo0 mg per day for 9 weeks	Drug	Placebo

Primary outcome

Number of Participants Who Are Cocaine Abstinent During the Last 2 Weeks of Treatment (Weeks 8-9), as Assessed by Urine Test
Time frame: 9 weeks
Urine samples were tested for benzoylecgonine, which is a metabolite of cocaine that is excreted in the urine. The presence of benzoylecgonine in the urine indicates cocaine use.

3 secondary outcomes

Proportion of Cocaine-positive Urines Per Week
Time frame: 9 weeks
Number of Participants With Cocaine-negative Urines Collected During Treatment Period
Time frame: 9 weeks
Retention as Assessed by Number of Participants Remaining in Treatment
Time frame: 9 weeks

Results and safety

Results posted to the registry on 31 Aug 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Citalopram Low Dose	21	13
Citalopram High Dose	44	23
Placebo	43	24

Primary outcome: Number of Participants Who Are Cocaine Abstinent During the Last 2 Weeks of Treatment (Weeks 8-9), as Assessed by Urine Test

Time frame: 9 weeks. Count of participants. Unit: Participants

Measure	Citalopram Low Dose n = 21	Citalopram High Dose n = 44	Placebo n = 43
Value	0	4	2

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 9 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Citalopram Low Dose	0 of 21 (0%)	9 of 21 (42.9%)	0 of 21
Citalopram High Dose	0 of 44 (0%)	20 of 44 (45.5%)	0 of 44
Placebo	1 of 43 (2.3%)	10 of 43 (23.3%)	0 of 43

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 39853194de Dios C, Suchting R, Green CE, Webber HE, Moeller FG, Lane SD, Schmitz J. The role of Iowa gambling task performance in response to citalopram treatment for cocaine use disorder. Am J Drug Alcohol Abuse. 2025 Jan 2;51(1):73-84. doi: 10.1080/00952990.2024.2420773. Epub 2025 Jan 24.

Related trials for Cocaine Dependence

Recruiting
rTMS and Cognitive-behavioral Therapy for Cocaine Use Disorder
Cocaine Use, Cocaine Dependence
Recruiting
Transcranial Direct Current Stimulation (tDCS) for Treatment of Substance Use Disorder
Cocaine Use Disorder, Cocaine Dependence
Not yet recruiting
QAIAx (AIhealth4U) - AI Smart Health Cities: Microcity Enclave Program (Quantum AI/AGI Agency a/k/a AI City Hall Project - UPSTO App Nos. 64/074,526, 64/063,557, 64/105,164, 63/903,181, 63/729,428, 64/125,360)
Asperger's Disorder, Asperger Disorder
RecruitingPhase 1
Safety Study of a Disrupted Adenovirus (Ad) Serotype Cocaine Vaccine for Cocaine-dependent Individuals
Cocaine Dependence
Active, not recruitingPhase 1
AAV8-hCocH for Cocaine Use Disorder
Cocaine Dependence, in Remission

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.

Joy M Schmitz, Ph.D. principal investigator

University of Texas at 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 Joy Schmitz 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 4 inclusion and 6 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 16 Sep 2020. 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 31 Aug 2020). 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?

Number of Participants Who Are Cocaine Abstinent During the Last 2 Weeks of Treatment (Weeks 8-9), as Assessed by Urine Test (time frame: 9 weeks). 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 NCT01535573, 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 16 Sep 2020.