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Varenicline-Methamphetamine Interaction Study
The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2009 by National Institute on Drug Abuse (NIDA).   Recruitment status was  Not yet recruiting

First Received on August 11, 2008.   Last Updated on April 23, 2009   History of Changes
Sponsor: National Institute on Drug Abuse (NIDA)
Information provided by: National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier: NCT00733967
  Purpose

The primary aim of the study is to determine the safety and tolerability of treatment with Varenicline in methamphetamine-dependent volunteers. The investigators also seek to determine the effects of treatment with Varenicline, as compared to placebo, on craving for methamphetamine or cigarettes following exposure to methamphetamine and smoking cues, respectively. The effects of treatment with Varenicline, as compared to placebo, on subjective effects produced by administration of methamphetamine or placebo will be attempted to be determined. Lastly, the investigators hope to determine the effects of treatment with Varenicline, as compared to placebo, on reinforcing effects produced by administration of methamphetamine or placebo.


Condition Intervention Phase
Methamphetamine Addiction
Drug: Varenicline
Drug: placebo
Phase I

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: A Human Laboratory Assessment of the Safety and Potential Efficacy of Varenicline In Methamphetamine-Dependent Volunteers Receiving Methamphetamine

Resource links provided by NLM:


Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:
  • Efficacy [ Time Frame: 8 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 13
Study Start Date: August 2009
Estimated Study Completion Date: July 2011
Estimated Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: I
Placebo capsules as control
Drug: placebo
placebo treatment daily
Experimental: II
Varenicline
Drug: Varenicline
Varenicline: 0.5 mg once daily for 3 days; 0.5 twice daily for 2 days; 1 mg twice daily for one day; 1 mg once daily for one day
Other Name: Chantix

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • English speaking volunteers who are not seeking treatment at the time of the study; Be between 18-55 years of age; Meet DSM-IV criteria for MA dependence; Must be cigarette smokers, defined as smoking 10 or more cigarettes per day by self-report; Have a self-reported history of using MA by the smoked or IV route and provide at least one MA-positive urine prior to admission; Have vital signs as follows: resting pulse between 50 and 90 bpm, blood pressures between 105-150 mm Hg systolic and 45-90 mm HG diastolic; this criterion must be met within 2 days of admission; Have hematology and chemistry laboratory tests that are within normal (+/- 10%) limits with the following exceptions: a) liver function tests (total Bilirubin, ALT, AST, and alkaline phosphatase) < 3 x the upper limit of normal, and b) kidney function tests (creatinine and BUN) < 2 x the upper limit of normal; Have a baseline EKG that demonstrates normal sinus rhythm, normal conduction (including QTc), and no clinically significant arrhythmias; Have a medical history and brief physical examination demonstrating no clinically significant contradictions for study participation, in the judgment of the admitting physician or nurse practitioner and the principal investigator

Exclusion Criteria:

  • Have any history or evidence suggestive of seizure disorder or brain injury; Have any previous medically adverse reaction to MA, including loss of consciousness, chest pain, or epileptic seizure; Have neurological or psychiatric disorders, such as: •psychosis, bipolar illness or major depression as assessed by MINI; •organic brain disease or dementia assessed by clinical interview;•history of any psychiatric disorder which would require ongoing treatment or which would make study compliance difficult;•history of suicide attempts within the past three months assessed by MINI and/or current suicidal ideation/plan as assessed by MINI; Have evidence of clinically significant heart disease or hypertension, as determined by the PI;Have a family history in first-degree relatives of early cardiovascular morbidity or mortality, as determined by the PI; Have evidence of untreated or unstable medical illness including: neuroendocrine, autoimmune, renal, hepatic, or active infectious disease; Have HIV and are currently symptomatic, have a diagnosis of AIDS, or are receiving antiretroviral medication; Be pregnant or nursing. Other females must either be unable to conceive (i.e., surgically sterilized, sterile, or post-menopausal) or be using a reliable form of contraception (e.g., abstinence, birth control pills, intrauterine device, condoms, or spermicide). All females must provide negative pregnancy urine tests before study entry, upon hospital admission, and at the end of study participation; Have asthma or currently use alpha or beta agonists, theophylline, or other sympathomimetics; Have any other illness, condition, or use of psychotropic medications, which in the opinion of the PI and/or the admitting physician or nurse practitioner would preclude safe and/or successful completion of the study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00733967

Contacts
Contact: Richard De La Garza, PhD 713-791-1414 ext 6020 rg12@bcm.tmc.edu
Contact: Thomas F. Newton, MD 713-791-1414 ext 6498 tnewton@bcm.edu

Locations
United States, Texas
Michael E. DeBakey VA Medical Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Investigators
Principal Investigator: Richard De La Garza, II, PhD Baylor College of Medicine
  More Information

No publications provided

Responsible Party: Dr. Richard De La Garza, II, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT00733967     History of Changes
Other Study ID Numbers: H-22707
Study First Received: August 11, 2008
Last Updated: April 23, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by National Institute on Drug Abuse (NIDA):
methamphetamine
chantix
varenicline

Additional relevant MeSH terms:
Behavior, Addictive
Compulsive Behavior
Impulsive Behavior
Methamphetamine
Amphetamine
Varenicline
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Dopamine Uptake Inhibitors
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents

ClinicalTrials.gov processed this record on February 09, 2012