Serotonin, Impulsivity, and Cocaine Dependence Treatment | NCT00297505

Studies
Serotonin, Impulsivity, and Cocaine Dependence Treatment

NCT00297505

Sponsor

National Institute on Drug Abuse (NIDA)

Status

Completed

Last Update Posted

Jan 12, 2017Estimated

Enrollment

120

Phase

Phase 2

Conditions

Cocaine Dependence

Interventions

citalopram

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2006

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2001

Primary Completion Date

Not provided

Completion Date

Nov 2004

First Submitted Date

Feb 27, 2006

First Submission Date that Met QC Criteria

Feb 27, 2006

First Posted Date

Feb 28, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 11, 2017

Last Update Posted Date

Jan 12, 2017Estimated

Description Module

Brief 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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120

Name	Type	Description	Arm Group Labels	Other Names
citalopram	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The presence of cocaine metabolites in urine weekly.

Secondary Outcomes

Measure	Description	Time Frame
Retention rate and cocaine cravings weekly.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

male and female subjects age 18 to 50 who currently meet DSM-IV criteria for cocaine dependence.
female subjects: a negative pregnancy test

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Frederick G Moeller, M.D.	The University of Texas Health Science Center, Houston	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Texas - Houston Health Science Center		Houston	Texas	77030	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
17613964	Derived	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.

ID	Term
D019970	Cocaine-Related Disorders
D007175	Impulsive Behavior

ID	Term
D019966	Substance-Related Disorders
D064419	Chemically-Induced Disorders
D001523	Mental Disorders
D001519	Behavior

ID	Term
D011437	Propylamines
D000588	Amines
D009930	Organic Chemicals
D009570	Nitriles
D001572