Clinical Neurobiology of Serotonin and Addiction

NCT00732901 | Completed Phase 2 Results DMC

• 3 other identifiers: HM15289 - 2P20DA024157DA 024157
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to examine the relationship between 5-HT2R function, impulsivity and cue reactivity in cocaine dependent subjects and healthy controls and examine specific effects of escitalopram and mirtazapine on impulsivity and cue reactivity in human cocaine users.

Conditions

Cocaine Dependence

Keywords

substance abuse; cocaine; impulsivity; serotonin; Remeron; Mirtzapine; Lexapro; Escatilopram

Outcome Measures

Primary Outcomes (1)

• Immediate Memory Task

  The IMT was used to measure impulsivity. The IMT is a continuous performance test. Subjects were instructed to respond on the computer's left mouse button when a five-digit number the target stimulus appeared that was exactly like the preceding stimulus. A catch stimulus was a number that differed only slightly from the preceding number. Only one of the five digits was changed its position and value was determined randomly. Responses errors made to catch stimuli were considered commission errors or 'false alarms'. Immediate Memory Task Commission Errors to catch stimuli were the primary measure of impulsivity in this study. Scale is percentage of overall responses to a catch stimulus that were commission errors, ranging from 0 to 100. Zero would equate to no impulsivity and 100 would equate to 100% impulsive responses.

  after acute dose and after chronic administration

Secondary Outcomes (2)

• Attentional Bias as Measured by the Cocaine Stroop Task.

  5 weeks of treatment

• Cocaine Positive Urines

  5 weeks of treatment

Study Arms (2)

A (escitalopram)

EXPERIMENTAL

Escitalopram

Drug: Escitalopram

B (placebo)

EXPERIMENTAL

Placebo

Drug: Placebo

Interventions

Escitalopram DRUG

Escitalopram: once daily 10 mg on days 1-3, 20 mg on days 4-24 and 10 mg on days 25-28

Also known as: Lexapro

A (escitalopram)

Placebo DRUG

Once daily days 1-28

B (placebo)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Non-Drug Abusing Control Subjects: Male and female subjects age 18 to 55 who do not meet current or past DSM-IV criteria for any Axis I disorder including substance abuse or dependence.
• Cocaine Dependent Subjects: Male and female subjects age 18 to 55 who meet current DSM-IV criteria for cocaine dependence.
• Female subjects: a negative pregnancy test.

You may not qualify if:

• Non-Drug Abusing Control Subjects:
• Current or past DSM-IV Axis I disorder
• Any serious non-psychiatric medical illness requiring ongoing medical treatment or which could affect the central nervous system.
• Positive HIV test.
• For female subjects: a positive pregnancy test or breast feeding.
• Concomitant use of prescription medications that could affect the central nervous system.
• Active suicidal ideation.
• Hamilton Depression or Anxiety Scale score greater than 15
• Cocaine Dependent Subjects:
• Current DSM-IV Axis I disorder other than substance abuse/dependence
• Current diagnosis of other substance dependence besides cocaine.
• Any serious non-psychiatric medical illness requiring ongoing medical treatment or which could affect the central nervous system.
• Positive HIV test.
• For female subjects: a positive pregnancy test or breast feeding.
• Concomitant use of prescription medications that could affect the central nervous system.

Sponsors & Collaborators

• Virginia Commonwealth University: lead
• National Institute on Drug Abuse (NIDA): collaborator
• The University of Texas Health Science Center, Houston: collaborator

Study Sites (1)

University of Texas Health Science Center-Houston; Substance Abuse Research Clinic

Houston, Texas, 77030, United States

Location

Related Publications (3)

• Liu S, Lane SD, Schmitz JM, Waters AJ, Cunningham KA, Moeller FG. Relationship between attentional bias to cocaine-related stimuli and impulsivity in cocaine-dependent subjects. Am J Drug Alcohol Abuse. 2011 Mar;37(2):117-22. doi: 10.3109/00952990.2010.543204. Epub 2011 Jan 5.

  PMID: 21204739 RESULT

• Anastasio NC, Liu S, Maili L, Swinford SE, Lane SD, Fox RG, Hamon SC, Nielsen DA, Cunningham KA, Moeller FG. Variation within the serotonin (5-HT) 5-HT(2)C receptor system aligns with vulnerability to cocaine cue reactivity. Transl Psychiatry. 2014 Mar 11;4(3):e369. doi: 10.1038/tp.2013.131.

  PMID: 24618688 RESULT

• Liu S, Lane SD, Schmitz JM, Cunningham KA, John VP, Moeller FG. Effects of escitalopram on attentional bias to cocaine-related stimuli and inhibitory control in cocaine-dependent subjects. J Psychopharmacol. 2013 Sep;27(9):801-7. doi: 10.1177/0269881113492898. Epub 2013 Jun 12.

  PMID: 23761390 RESULT

MeSH Terms

Conditions

Cocaine-Related Disorders; Substance-Related Disorders; Impulsive Behavior

Interventions

Escitalopram

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Behavior

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: F. Gerard Moeller
• Organization: Virginia Commonwealth University

fgmoeller@vcu.edu

804-828-4134

Study Officials

• Frederick G Moeller, MD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2008
• First Posted: August 12, 2008
• Study Start: June 1, 2008
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: March 8, 2019
• Results First Posted: March 30, 2017

Record last verified: 2017-06

Locations

US (1)