Varenicline-Methamphetamine Interaction Study (2008)

This study has been withdrawn prior to enrollment.
(No longer active)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Richard De La Garza, Baylor College of Medicine
ClinicalTrials.gov Identifier:
NCT00733967
First received: August 11, 2008
Last updated: July 25, 2012
Last verified: July 2012
  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 Dependence
Substance Abuse
Methamphetamine Abuse
Drug: Varenicline
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
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 Baylor College of Medicine:

Primary Outcome Measures:
  • Effects of varenicline and methamphetamine on cardiovascular measures. [ Designated as safety issue: Yes ]
    The safety of MA administration during treatment will be assessed by reporting of adverse events (AEs), and using ECG recording, and heart rate and blood pressure measurements. Digital 12-lead EKG will also be recorded prior to randomization. Blood pressure and heart rate will be measured from 15 min prior to MA or placebo dosing until 2 h after dosing. In addition, heart rate and blood pressure will be assessed throughout the inpatient portion of the protocol.


Secondary Outcome Measures:
  • Effects of varenicline and methamphetamine on subjective measures [ Designated as safety issue: No ]
    Efficacy will be assessed by measuring effects of treatment on subjective and reinforcing effects produced by administration of MA and craving produced by exposure to drug cues. Other diagnostic measures and assessment instruments will be used to further characterize the study population.


Enrollment: 0
Study Start Date: January 2008
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Matching oral placebo capsules as control.
Drug: Placebo
Matching oral placebo capsules as control.
Other Name: Sugar pill
Active Comparator: Varenicline
See assigned interventions.
Drug: Varenicline
Varenicline (oral capsule): 0.5 mg once daily for 3 days; 0.5 mg twice daily for 2 days; 1 mg twice daily for one day; 1 mg once daily for one day.
Other Name: Chantix

Detailed Description:

See Brief Summary

  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
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: NCT00733967

Sponsors and Collaborators
Baylor College of Medicine
Investigators
Principal Investigator: Richard De La Garza, II, PhD Baylor College of Medicine
  More Information

No publications provided

Responsible Party: Richard De La Garza, Associate Professor, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT00733967     History of Changes
Other Study ID Numbers: H-22707, P50DA018185, DPMC, 2P50DA018197-06
Study First Received: August 11, 2008
Last Updated: July 25, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Baylor College of Medicine:
Methamphetamine
Chantix
Varenicline

Additional relevant MeSH terms:
Substance-Related Disorders
Mental Disorders
Methamphetamine
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 July 22, 2014