CompletedPhase 1

An Assessment of the Safety of Varenicline in Methamphetamine-dependent Volunteers

United States8 participantsStarted 2008-07

Plain-language summary

More people worldwide use amphetamine-type stimulants than any illicit drug besides cannabis, and methamphetamine (MA) abuse and dependence is the fastest growing drug problem in the United States. Much work remains in identifying an effective pharmacotherapy for MA dependence. The neurobiological actions produced by MA involve dopamine (DA), serotonin, and norepinephrine, but also include alterations to cholinergic neurotransmitter systems. Candidate compounds that target acetylcholine (ACh) are attractive options for development that have not received adequate attention. Varenicline is a drug that increases the release of DA in the brain and it is logical to assume that it would to some extent compensate for the reduction in these neurotransmitters that occurs in MA withdrawal. Current research has linked certain genes that are related to neurotransmitters with drug abuse and memory impairment (e.g., A1 allele for the D2 dopamine receptor and catechol-O-methyltransferase). We will take blood samples and test for these genes in order to relate the findings to brain function. This is a double-blind, placebo-controlled, within-subjects study to determine the safety and tolerability of MA in MA-dependent volunteers treated with varenicline and placebo.

Who can participate

Age range18 Years – 55 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Be English-speaking volunteers who are not seeking treatment at the time of the study;
✓. Be between 18-55 years of age;
✓. Meet DSM-IV TR 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;

Exclusion criteria

What they're measuring

Systolic Blood Pressure

Timeframe: 15 minute intervals

Diastolic Blood Pressure

Timeframe: 15 minute intervals

Heart Rate

Timeframe: 15 minute intervals

Trial details

NCT IDNCT00713479

SponsorUniversity of California, Los Angeles

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2009-08

Results submitted2013-03-26

View on ClinicalTrials.gov More Methamphetamine Addiction trials

Plain-language summary

Who can participate

Age range18 Years – 55 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Be English-speaking volunteers who are not seeking treatment at the time of the study;
✓. Be between 18-55 years of age;
✓. Meet DSM-IV TR 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;