NCT01498549

Brief Summary

The overall goal of this study is to determine if atomoxetine treatment improves selective cognitive functions in abstinent cocaine users, compared to healthy controls. The study will also test if a functional variation of the NET promoter polymorphic region (NETpPR) moderates the cognitive effects of atomoxetine.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2011

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, 2011

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

December 20, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 23, 2011

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
3.9 years until next milestone

Results Posted

Study results publicly available

June 8, 2017

Completed
Last Updated

July 11, 2017

Status Verified

June 1, 2017

Enrollment Period

1.6 years

First QC Date

December 20, 2011

Results QC Date

February 8, 2017

Last Update Submit

June 8, 2017

Conditions

Addiction

Keywords

Abstinent cocaine userscognitive testing

Outcome Measures

Primary Outcomes (2)

  • Rapid Visual Information Processing

    Cognitive Test to determine the speed of Visual information. The CANTAB Rapid Visual Information Processing test (RVP) is a measure of sustained attention with a small working memory component (Sahakian and Owen, 1992). Digits are rapidly (100/minute) and pseudo-randomly presented for 7 minutes. Subjects are instructed to press when the third digit of a target sequence (e.g. 3-5-7) is displayed. Primary outcomes are indices of target discriminability (A') and response bias (B") and response latency to targets.

    2 years

  • Rapid Visual Information Processing: Mean Correct Response Latency

    Cognitive Test to determine the speed of Visual information. The CANTAB Rapid Visual Information Processing test (RVP) is a measure of sustained attention with a small working memory component (Sahakian and Owen, 1992). Digits are rapidly (100/minute) and pseudo-randomly presented for 7 minutes. Subjects are instructed to press when the third digit of a target sequence (e.g. 3-5-7) is displayed. Primary outcomes are indices of target discriminability (A') and response bias (B") and response latency to targets.

    2 years

Study Arms (2)

Atomoxetine

ACTIVE COMPARATOR

Atomoxetine compared to the sugar pill

Drug: Sugar Pill

Sugar Pill

PLACEBO COMPARATOR

Sugar pill compared to atomoxetine

Drug: Atomoxetine

Interventions

AtomoxetineDRUG

Atomoxetine 40mg and 80mg compared to the sugar pill

Also known as: Strattera
Sugar Pill
Sugar PillDRUG

Sugar pill compared to Atomoxetine 40mg and 80mg.

Also known as: placebo
Atomoxetine

Eligibility Criteria

Age21 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Male and females, between the ages of 21 and 50;
  • No current dependence or abuse of drugs of abuse or alcohol (except and tobacco);
  • No current medical problems and normal ECG;
  • For women, not pregnant as determined by pregnancy screening nor breast feeding, and using acceptable birth control methods.

You may not qualify if:

  • Current major psychiatric illnesses including mood, psychotic, or anxiety disorders;
  • History of major medical illnesses; including liver diseases, heart disease, or other medical conditions that the physician investigator deems contraindicated for the subject to be in the study;
  • Known allergy to Atomoxetine;
  • Use of Monoamine Oxidase inhibitor within the last month (clinically Atomoxetine administration is contraindicated with or within 2 weeks of discontinuation of Monoamine oxidase inhibitor therapy).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Veterans Affairs

West Haven, Connecticut, 06516, United States

Location

MeSH Terms

Conditions

Behavior, Addictive

Interventions

Atomoxetine HydrochlorideSugars

Condition Hierarchy (Ancestors)

Compulsive BehaviorImpulsive BehaviorBehavior

Intervention Hierarchy (Ancestors)

PropylaminesAminesOrganic ChemicalsCarbohydrates

Results Point of Contact

Title
Dr. Mehmet Sofuoglu, Professor of Psychiatry; Director of VA New England Mental Illness Research, Ed
Organization
Yale University
mehmet.sofuoglu@yale.edu
(203) 937-4809

Study Officials

  • Mehmet Sofuoglu, M.D., Ph.D.

    Yale University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prinicipal Investigator

Study Record Dates

First Submitted

December 20, 2011

First Posted

December 23, 2011

Study Start

December 1, 2011

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

July 11, 2017

Results First Posted

June 8, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)