Clinical trial NCT01408589: A Dose Response Effect of Atomoxetine to the Acute Effects of Alcohol
Official title: A Pharmacotherapy Study: A Dose Response Effect of Atomoxetine on Alcohol-elicited Craving and Sensitivity to the Acute Effects of Alcohol
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Alcohol Craving
Mood Changes
Keywords: alcohol
craving
mood
optimum dose of atomoxetine
Lead sponsor: University of Colorado, Boulder
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
name: National Center for Research Resources (NCRR)
First posted: 2011-08-03
Enrollment: 86
Sex: ALL
Minimum age (years): 21
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Alcohol Craving
timeFrame: Day 5 of medication
Secondary outcomes:
measure: Genetic moderation
timeFrame: day 5 of medication
Other outcomes:
Locations:
city: Boulder
country: United States
facility: GCRC, University of Colorado Boulder
state: Colorado
Study officials:
affiliation: University of Colorado, Boulder
name: Heather M Haughey, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: