NCT01535573

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
108

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Dec 2010

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2010

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

October 24, 2011

Completed
4 months until next milestone

First Posted

Study publicly available on registry

February 17, 2012

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
4.2 years until next milestone

Results Posted

Study results publicly available

August 31, 2020

Completed
Last Updated

September 16, 2020

Status Verified

August 1, 2020

Enrollment Period

5.6 years

First QC Date

October 24, 2011

Results QC Date

August 13, 2020

Last Update Submit

August 29, 2020

Conditions

Cocaine Dependence

Keywords

Cocainecitalopramtreatmentserotonin

Outcome Measures

Primary Outcomes (1)

  • 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.

    9 weeks

Secondary Outcomes (3)

  • Proportion of Cocaine-positive Urines Per Week

    9 weeks

  • Number of Participants With Cocaine-negative Urines Collected During Treatment Period

    9 weeks

  • Retention as Assessed by Number of Participants Remaining in Treatment

    9 weeks

Study Arms (3)

Citalopram low dose

ACTIVE COMPARATOR

Citalopram 20 mg

Drug: Citalopram

Citalopram high dose

ACTIVE COMPARATOR

Citalopram 40 mg

Drug: Citalopram

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

CitalopramDRUG

20 mg once per day for 9 weeks

Citalopram low dose
PlaceboDRUG

0 mg per day for 9 weeks

Placebo

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UT-Houston Behavioral and Biomedical Sciences Building

Houston, Texas, 77054, United States

Location

MeSH Terms

Conditions

Cocaine-Related Disorders

Interventions

Citalopram

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PropylaminesAminesOrganic ChemicalsNitrilesBenzofuransHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Results Point of Contact

Title
Joy M. Schmitz, PhD, Professor and Director of Center For Neurobehavioral Research On Addictions
Organization
The University of Texas Health Science Center at Houston
Joy.M.Schmitz@uth.tmc.edu

Study Officials

  • Joy M Schmitz, Ph.D.

    University of Texas at Houston

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor , Behavioral Sciences

Study Record Dates

First Submitted

October 24, 2011

First Posted

February 17, 2012

Study Start

December 1, 2010

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

September 16, 2020

Results First Posted

August 31, 2020

Record last verified: 2020-08

Locations

US(1)