Alcohol Sensitivity Clinical Trial
— ATXOfficial title:
A Gene by Medication Interaction to the Acute Effects of Alcohol
| Verified date | May 2012 |
| Source | University of Virginia |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
Alcohol dependence, or "alcoholism", affects approximately 14 million Americans. Currently,
only three pharmacotherapies (disulfiram, naltrexone, and acamprosate) have been approved
for the treatment of alcohol dependence and these medications are, at best, moderately
successful. Thus, there is a great need for the examination of other biological systems,
which contribute/influence the drug reward/addiction pathways within the brain, such that
the discovery of new targets and new pharmacotherapies will be possible. Other biological
systems in addition to dopamine, such as serotonin, and norepinephrine (NE) are thought to
be important in several aspects of addiction, including reward, craving and depression.
This study will examine the effects of a 5 day course of atomoxetine (a selective NE
transporter (NET) inhibitor) (80 mg/day; Strattera or placebo) 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 study, of 64 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.
| Status | Terminated |
| Enrollment | 43 |
| Est. completion date | April 2012 |
| Est. primary completion date | February 2012 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 21 Years to 45 Years |
| Eligibility |
Inclusion Criteria: - Males and females age 21 - 45, as verified upon the presentation of a valid, government issued form of ID - Current DSM-IV diagnosis of alcohol dependence using the Mini International Neuropsychiatric Interview (MINI). Which is a shortened form of the Structured Clinical Interview for the Diagnostic and Statistical Manual of Mental Disorders or SCID. The MINI will also be used to exclude patients with other diagnoses. - Participants do not meet DSM-IV criteria for any current (i.e., criteria met at any point in the past 30 days) Axis I disorder (including ADHD treated with medication), other than cocaine dependence or those listed above, that warrants treatment or would preclude safe participation in the protocol - Not currently take medications that are contraindicated for concurrent use with alcohol; - No subjects who have trouble reading the English language or visual or hearing problems that may interfere with the collection of data; - No recurring past history of severe hypertension, glaucoma, hyperthyroidism, circulatory disease, hepatitis, chronic liver disease, ulcer disease, seizure disorder, brain disease, cardiac disease, obstructed bowel, or other current treatment of medical conditions that could determine ineligibility; - Female subjects must not be breastfeeding and must not be pregnant, as indicated by a pregnancy test that will be conducted immediately prior dispensing of medication. - Subjects have to have normal EKGs results - Pulse less than 100 beats per minute - Participants have to weigh between 125-290; weighing between 125-195 lbs (57 - 88.5 kg) Exclusion Criteria: - Significant medical illness (including severe hypertension) as determined by history and/or complete physical examination. (Note: Presence of mild to moderate chronic diseases not otherwise specifically excluded, that are well controlled by medications/interventions will not be considered clinically significant. However the presence of medical disease that is not well controlled will be considered exclusionary.) - tachycardia - seizure disorder - prior history of myocardial infarction - Clinically significant cardiovascular disease that precludes safe participation - hepatic or renal impairment; (ie: liver or kidney enzymes > 3x normal limits) - pregnant - currently using MAO inhibitors within 14 days - narrow angle glaucoma - currently taking antidepressants or have taken within the last month - currently taking pressor agents such as: - Alprenolol - Carteolol - Levobunolol - Mepindolol - Metipranolol - Nadolol - Oxprenolol - Penbutolol - Pindolol - Propranolol - Sotalol - Timolol - Acebutolol - Atenolol - Betaxolol - Bisoprolol[16] - Esmolol - Metoprolol - Nebivolol - Carvedilol - Celiprolol - Labetalol - Butaxamine |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science
| Country | Name | City | State |
|---|---|---|---|
| United States | Center for Addiction Research and Education | Charlottesville/ Richmond | Virginia |
| Lead Sponsor | Collaborator |
|---|---|
| University of Virginia | National Institute on Alcohol Abuse and Alcoholism (NIAAA) |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Alcohol urge questionnaire | This questionnaire is used to assess craving. The AUQ consists of eight items related to urge drink that are rated on a 7-point Likert scale with the extremes anchored by "Strongly Disagree" and "Strongly Agree." The AUQ has demonstrated internal consistency and reliability (Bohn et al., 1995). | On day 5 of medication | No |
| Secondary | Biphasic Alcohol Effects Scale (BAES) | On day 5 of medication | No |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01845220 -
Prevention of Alcohol Intolerance
|
Phase 2 |