NCT01408589

Brief Summary

This two-stage study will examine the effects of a 5 day course of atomoxetine (placebo, 40, 60 or 80 mg/day; Strattera) (a selective NE transporter (NET) inhibitor) on alcohol-elicited craving and sensitivity to alcohol. The novelty of this study is that of atomoxetine and the fact that it targets NET, neither of which has heretofore been examined in the context of alcohol dependence. It is hopeful that this pilot study, of 86 total individuals, will provide the PI with sufficient preliminary data to submit a subsequent R01 application to study atomoxetine and the involvement of specific single nucleotide polymorphisms within the NET gene on alcohol-related phenotypes in alcohol dependent and non-dependent populations. The long-term objective of this research is to develop more efficacious treatment interventions for alcohol abuse and dependence. Hypothesis 1: It is hypothesized that subjects who receive 40, 60 or 80 mg/day of atomoxetine for 5 days will demonstrate significantly less alcohol-elicited craving than subjects who receive a placebo. Hypothesis 2: It is hypothesized that subjects who receive 40, 60 or 80 mg/day of atomoxetine for 5 days will be less sensitive to the acute effects of alcohol (subjective intoxication) than subjects who receive a placebo.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
86

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jun 2005

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2005

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

July 12, 2011

Completed
22 days until next milestone

First Posted

Study publicly available on registry

August 3, 2011

Completed
Last Updated

August 3, 2011

Status Verified

August 1, 2011

Enrollment Period

2.5 years

First QC Date

July 12, 2011

Last Update Submit

August 2, 2011

Conditions

Alcohol CravingMood Changes

Keywords

alcoholcravingmoodoptimum dose of atomoxetine

Outcome Measures

Primary Outcomes (1)

  • Alcohol Craving

    Alcohol craving and sensitivity were measured with the AUQ, ARS, POMS, BAES and SHAS

    Day 5 of medication

Secondary Outcomes (1)

  • Genetic moderation

    day 5 of medication

Study Arms (4)

Sugar Pill

PLACEBO COMPARATOR
Drug: Atomoxetine, Strattera

Atomoxetine 40 mg

EXPERIMENTAL
Drug: Atomoxetine, Strattera

Atomoxetine 60 mg

EXPERIMENTAL
Drug: Atomoxetine, Strattera

Atomoxetine 80 mg

EXPERIMENTAL
Drug: Atomoxetine, Strattera

Interventions

Atomoxetine, StratteraDRUG

Atomoxetine at 0, 40, 60, 80 mg/day was given for 5 days, all subjects took two capsules per day for 5 days; all active dose groups received 40 mg/day for first 3 days and where then dose escalated to dosage group assigned.

Atomoxetine 40 mgAtomoxetine 60 mgAtomoxetine 80 mgSugar Pill

Eligibility Criteria

Age21 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Inclusion Criterion: 1. Males and females age 21 to 35, as verified upon the presentation of a valid driver's license; 2. Must drink alcohol at least twice a week and have a minimum of 3 drinks per occasion (2 for women); 3. Must score 8 or higher on the Alcohol Use Disorders Identification Test (AUDIT; Babor et al., 1992). The AUDIT is a screening instrument used to identify persons whose alcohol consumption is characterized by moderate to heavy drinking; 4. No history of alcohol treatment or desire for treatment; 5. Not currently take medications that are contraindicated for concurrent use with alcohol; 6. Female subjects must not be pregnant, as indicated by a pregnancy test that will be conducted immediately prior dispensing of medication. Exclusion Criterion: Subjects who have hypertension, tachycardia, cardiovascular disease, hepatic or renal impairment, pregnant or who are currently using MAO inhibitors, Albuterol or other pressor agents will be excluded from this study.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

GCRC, University of Colorado Boulder

Boulder, Colorado, 80309, United States

Location

MeSH Terms

Interventions

Atomoxetine Hydrochloride

Intervention Hierarchy (Ancestors)

PropylaminesAminesOrganic Chemicals

Study Officials

  • Heather M Haughey, Ph.D.

    University of Colorado, Boulder

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 12, 2011

First Posted

August 3, 2011

Study Start

June 1, 2005

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

August 3, 2011

Record last verified: 2011-08

Locations

US(1)