A Dose Response Effect of Atomoxetine to the Acute Effects of Alcohol

NCT ID: NCT01408589

Last Updated: 2011-08-03

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 86 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-06-30
• Study Completion Date: 2007-12-31

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.

Conditions

Alcohol Craving; Mood Changes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: QUADRUPLE

Study Groups

Sugar Pill

Group Type: PLACEBO_COMPARATOR

Atomoxetine, Strattera

Intervention Type: DRUG

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 mg

Group Type: EXPERIMENTAL

Atomoxetine, Strattera

Intervention Type: DRUG

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 60 mg

Group Type: EXPERIMENTAL

Atomoxetine, Strattera

Intervention Type: DRUG

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 80 mg

Group Type: EXPERIMENTAL

Atomoxetine, Strattera

Intervention Type: DRUG

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.

Interventions

Atomoxetine, Strattera

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role: collaborator

National Center for Research Resources (NCRR)

NIH

Sponsor Role: collaborator

University of Colorado, Boulder

OTHER

Sponsor Role: lead

Responsible Party

University of Colorado, Boulder

Principal Investigators

Heather M Haughey, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Boulder

Locations

GCRC, University of Colorado Boulder

Boulder, Colorado, United States

Countries

United States

Other Identifiers

K01AA015331

Identifier Type: NIH

Identifier Source: secondary_id

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M01RR000051

Identifier Type: NIH

Identifier Source: secondary_id

View Link

B5089

Identifier Type: -

Identifier Source: org_study_id