A Dose Response Effect of Atomoxetine to the Acute Effects of Alcohol (ATX_COMT)

This study has been terminated.
Sponsor:
Collaborators:
Information provided by:
University of Colorado, Boulder
ClinicalTrials.gov Identifier:
NCT01408589
First received: July 12, 2011
Last updated: August 2, 2011
Last verified: August 2011
  Purpose

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.


Condition Intervention Phase
Alcohol Craving
Mood Changes
Drug: Atomoxetine, Strattera
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: A Pharmacotherapy Study: A Dose Response Effect of Atomoxetine on Alcohol-elicited Craving and Sensitivity to the Acute Effects of Alcohol

Resource links provided by NLM:


Further study details as provided by University of Colorado, Boulder:

Primary Outcome Measures:
  • Alcohol Craving [ Time Frame: Day 5 of medication ] [ Designated as safety issue: No ]
    Alcohol craving and sensitivity were measured with the AUQ, ARS, POMS, BAES and SHAS


Secondary Outcome Measures:
  • Genetic moderation [ Time Frame: day 5 of medication ] [ Designated as safety issue: No ]

    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



Enrollment: 86
Study Start Date: June 2005
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Sugar Pill 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.
Experimental: Atomoxetine 40 mg 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.
Experimental: Atomoxetine 60 mg 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.
Experimental: Atomoxetine 80 mg 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.

  Eligibility

Ages Eligible for Study:   21 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01408589

Locations
United States, Colorado
GCRC, University of Colorado Boulder
Boulder, Colorado, United States, 80309
Sponsors and Collaborators
University of Colorado, Boulder
Investigators
Principal Investigator: Heather M Haughey, Ph.D. University of Colorado, Boulder
  More Information

No publications provided

Responsible Party: Heather M. Haughey, P.I., University of Colorado, Boulder
ClinicalTrials.gov Identifier: NCT01408589     History of Changes
Other Study ID Numbers: B5089, K01AA015331, M01RR000051
Study First Received: July 12, 2011
Last Updated: August 2, 2011
Health Authority: United States: Food and Drug Administration
United States: University of Colorado Boulder SAC GCRC
United States: University of Colorado BoulderHuman Advisory Committee(IRB)

Keywords provided by University of Colorado, Boulder:
alcohol
craving
mood
optimum dose of atomoxetine

Additional relevant MeSH terms:
Atomoxetine
Adrenergic Uptake Inhibitors
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 26, 2014