Varenicline-Methamphetamine Interaction Study (2008)

Baylor College of Medicine

Status and phase

Withdrawn

Phase 1

Conditions

Methamphetamine Dependence

Substance Abuse

Methamphetamine Abuse

Treatments

Drug: Varenicline

Drug: Placebo

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00733967

P50DA018185 (U.S. NIH Grant/Contract)

DPMC

2P50DA018197-06 (U.S. NIH Grant/Contract)

H-22707

Details and patient eligibility

About

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.

Full description

See Brief Summary

Sex

All

Ages

18 to 55 years old

Volunteers

No Healthy Volunteers

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