Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
National Institute on Drug Abuse (NIDA) |
---|---|
Information provided by: | National Institute on Drug Abuse (NIDA) |
ClinicalTrials.gov Identifier: | NCT00713479 |
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, and subjective and reinforcing effects of MA in MA-dependent volunteers treated with varenicline and placebo.
Condition | Intervention | Phase |
---|---|---|
Behavior Addictive |
Drug: Varenicline Drug: Placebo |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Safety Study |
Official Title: | A Human Laboratory Assessment of the Safety and Potential Efficacy of Varenicline in Methamphetamine-Dependent Volunteers Receiving Methamphetamine |
Estimated Enrollment: | 13 |
Study Start Date: | July 2008 |
Estimated Study Completion Date: | September 2008 |
Estimated Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Arm 2: Placebo Comparator |
Drug: Placebo
Placebo dosing will begin at 0.5 mg once daily for the first 3 days and will be increased to 0.5 mg twice daily for the days 5-6, and increased to 1 mg once daily on days 7-10.
|
Arm 1: Active Comparator |
Drug: Varenicline
Varenicline dosing will begin at 0.5 mg once daily for the first 3 days and will be increased to 0.5 mg twice daily for the days 5-6, and increased to 1 mg once daily on days 7-10.
|
Study Procedures:
This study will enroll 13 participants meeting criteria for MA dependence who are not seeking treatment, and who also meet criteria for nicotine dependence. Participants will be asked to wear a telemetry device during screening and throughout the study that records heart rate and body temperature. Participants will be required to refrain from smoking at certain times, illicit and prescription drug use for the duration of the study and this will be confirmed with daily urine testing.
The study consists of 30 days or less of outpatient screening. The 2-phase inpatient portion of the study lasts a total of 18 days. Participants will be admitted to the GCRC at UCLA for Days 1-10. After the first study day, participants will be randomized to varenicline or matched placebo for 9-days and then discharged from the GCRC. Then, after 2-4 weeks, the same subjects return to the GCRC to be switched to the alternate condition for the second phase of the study, which lasts another 8-days. Each subject is randomized to both varenicline and placebo, so total time commitment is 18 inpatient study days. One follow-up visit is scheduled 2 weeks after completion of both study phases for assessment of delayed adverse events and for final payment.
Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Have neurological or psychiatric disorders, such as
Contact: Todd Zorick, MD | 888-791-9988 | TZorick@mednet.ucla.edu |
Contact: Thomas Hanson, MA | 888-791-9988 | THanson@mednet.ucla.edu |
United States, California | |
UCLA NPI | Recruiting |
Los Angeles, California, United States, 90095 |
Principal Investigator: | Edythe D London, PhD | UCLA NPI |
Responsible Party: | UCLA Dept of Family Medicine ( Steven Shoptaw, PhD ) |
Study ID Numbers: | 18185-PI-EDL-V |
Study First Received: | July 10, 2008 |
Last Updated: | July 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00713479 |
Health Authority: | United States: Food and Drug Administration |
methamphetamine varenicline Chantix stimulant |
Methamphetamine Dopamine Amphetamine |
Dopamine Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Adrenergic Agents Sympathomimetics Adrenergic Uptake Inhibitors Physiological Effects of Drugs |
Central Nervous System Stimulants Pharmacologic Actions Autonomic Agents Therapeutic Uses Dopamine Agents Peripheral Nervous System Agents Central Nervous System Agents |