A Dose Response Effect of Atomoxetine to the Acute Effects of Alcohol (ATX_COMT)
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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 |
- 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
- 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 |
Inclusion Criterion:
- Males and females age 21 to 35, as verified upon the presentation of a valid driver's license;
- Must drink alcohol at least twice a week and have a minimum of 3 drinks per occasion (2 for women);
- 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;
- No history of alcohol treatment or desire for treatment;
- Not currently take medications that are contraindicated for concurrent use with alcohol;
- 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| United States, Colorado | |
| GCRC, University of Colorado Boulder | |
| Boulder, Colorado, United States, 80309 | |
| 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 May 22, 2013