An ACE Inhibitor (Perindopril) or an Angiotensin Receptor Blocker (Candesartan) as a Treatment for Methamphetamine Dependence
The primary objective is to determine the dose dependent effects of treatment with perindopril on methamphetamine (MA)-induced craving and on the reinforcing effects of MA indexed by MA self-administration. We will also determine the effects of treatment with candesartan on MA-induced craving and on the reinforcing effects of MA indexed by MA self-administration.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
|Official Title:||An ACE Inhibitor or an Angiotensin Receptor Blocker as a Treatment for Methamphetamine Dependence|
- The dose-dependent effects of an ace inhibitor or an angiotensin receptor blocker on MA- and cue-induced craving and on the reinforcing effects of MA indexed by MA self-administration. [ Time Frame: 7 days ] [ Designated as safety issue: No ]Participants demonstrating MA-induced craving will then be randomized to active study medication (perindopril or candesartan) or matched placebo (day 0). Over days 4 to 7 a variety of procedures will be completed to assess effects of MA and cue-induced craving. On day 7, reinforcing effects will be assessed will be assessed using self-administration procedures.
- The effects of an ace inhibitor or an angiotensin receptor blocker on subjective measures. [ Time Frame: 7 days ] [ Designated as safety issue: No ]On days 3 and 5, participants will receive sample doses of 15mg or 30mg MA paired with a dose of placebo saline separated by 180 min, with the order of administration randomized. Subjective effects of MA will be assessed using visual analogue scales (VAS).
|Study Start Date:||May 2009|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
|Placebo Comparator: Placebo||
Placebo treatment daily.
Other Name: Sugar pill
|Active Comparator: Perindopril||
8 mg taken orally from days 0 through 7.
Other Name: Aceon
|Active Comparator: Candesartan||
16 mg taken orally from days 0 through 7.
Other Name: Atacand
Our preliminary data indicate that the ACE inhibitor perindopril can attenuate MA-induced drug craving, suggesting that perindopril should be evaluated as a treatment for MA dependence. Candesartan works similarly to perindopril but should lack the U-shaped dose response. Like perindopril, candesartan is used for hypertension. Whereas perindopril reduces the synthesis of angiotensin II, candesartan blocks angiotensin II receptors.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01062451
|Contact: Thomas F Newton, MD||877-228-5777||SARP@bcm.edu|
|Contact: Richard De La Garza, Ph. D||877-228-5777||SARP@bcm.edu|
|United States, Texas|
|Michael E. DeBakey VA Medical Center||Recruiting|
|Houston, Texas, United States, 77030|
|Principal Investigator: Thomas F Newton, M.D.|
|Principal Investigator:||Thomas F Newton, M.D.||Baylor College of Medicine|