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

Alcohol Craving Clinical Trial

— ATX_COMT  

Official title:

A Pharmacotherapy Study: A Dose Response Effect of Atomoxetine on Alcohol-elicited Craving and Sensitivity to the Acute Effects of Alcohol

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01408589
• Other study ID #: B5089
• Secondary ID: K01AA015331M01RR
• Status: Terminated
• Phase: Phase 1
• First received: July 12, 2011
• Last updated: August 2, 2011
• Start date: June 2005
• Est. completion date: December 2007

Study information

• Verified date: August 2011
• Source: University of Colorado, Boulder
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: University of Colorado Boulder SAC GCRCUnited States: University of Colorado BoulderHuman Advisory Committee(IRB)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 86
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 45 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Alcohol Craving
• Mood Changes

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
United States	GCRC, University of Colorado Boulder	Boulder	Colorado

Sponsors (3)

Lead Sponsor	Collaborator
University of Colorado, Boulder	National Center for Research Resources (NCRR), National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Alcohol Craving	Alcohol craving and sensitivity were measured with the AUQ, ARS, POMS, BAES and SHAS	Day 5 of medication	No
Secondary	Genetic moderation	To determine whether two functional SNPs within the COMT and DBH genes moderate the effects of EtOH and or atomoxetine.; COMT Val158Met (G/A), Val > Met 2-4x plasma activity DBH -1021 C/T, C/C has 3x more plasma activity NET gene variants were also examined	day 5 of medication	No