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

This study has been terminated.
Sponsor:
Collaborators:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
National Center for Research Resources (NCRR)
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
History of Changes

July 12, 2011
August 2, 2011
June 2005
December 2007   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01408589 on ClinicalTrials.gov Archive Site
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
Same as current
Not Provided
Not Provided
 
A Dose Response Effect of Atomoxetine to the Acute Effects of Alcohol
A Pharmacotherapy Study: A Dose Response Effect of Atomoxetine on Alcohol-elicited Craving and Sensitivity to the Acute Effects of Alcohol

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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
  • Alcohol Craving
  • Mood Changes
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.
  • Placebo Comparator: Sugar Pill
    Intervention: Drug: Atomoxetine, Strattera
  • Experimental: Atomoxetine 40 mg
    Intervention: Drug: Atomoxetine, Strattera
  • Experimental: Atomoxetine 60 mg
    Intervention: Drug: Atomoxetine, Strattera
  • Experimental: Atomoxetine 80 mg
    Intervention: Drug: Atomoxetine, Strattera
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
86
December 2007
December 2007   (final data collection date for primary outcome measure)

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.
Both
21 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01408589
B5089, K01AA015331, M01RR000051
Yes
Heather M. Haughey, P.I., University of Colorado, Boulder
University of Colorado, Boulder
  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)
  • National Center for Research Resources (NCRR)
Principal Investigator: Heather M Haughey, Ph.D. University of Colorado, Boulder
University of Colorado, Boulder
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP