Ignite Creation Date:
2024-05-06 @ 9:21 AM
Last Modification Date:
2024-10-26 @ 12:13 PM
Study NCT ID:
NCT02968602
Status:
COMPLETED
Last Update Posted:
2022-01-06
First Post:
2016-11-15
Brief Title:
Minocycline and Tobacco Craving in Smokers With Schizophrenia
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Minocycline and Tobacco Craving in Smokers With Schizophrenia
Status:
COMPLETED
Status Verified Date:
2022-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Craving for cigarettes is an important aspect that leads to challenges with smoking cessation Persons with schizophrenia are more likely to smoke and to be heavier smokers than persons without schizophrenia and may experience craving differently as well Minocycline is an antibiotic medication that may impact craving We will conduct a two-week randomized double-blind placebo-controlled parallel group pilot study to investigate the effects of minocycline vs placebo on craving and smoking behaviors in smokers with schizophrenia Participants will take minocycline or matching placebo for two weeks Participants will be assessed on aspects of craving and smoking behavior at baseline and after 1 and 2 weeks of minocycline or placebo treatment
Detailed Description:
Nicotine dependence is high in schizophrenia nearly three times more prevalent than the general population In smokers with schizophrenia the risk of all-cause mortality is doubled and cardiovascular mortality risk is twelvefold higher than nonsmokers Many factors influence smoking in persons with schizophrenia but predictors of craving and smoking behavior are not well established Craving is a major contributor to smoking behaviors and importantly is a predictor of relapse risk Since craving may precede relapse it can be advantageous as a screening tool for those attempting cessation In addition focusing on treatments aimed to reduce craving may lead to better therapeutic targets Minocycline may affect craving perhaps due to inhibition of nitric oxide NO formation as NO acts as a second messenger for glutamate and dopamine receptors NO also facilitates the effects of nicotine in the reward circuit and blockade of NO has been demonstrated to eliminate nicotine abstinence symptoms in rats A small study has demonstrated that minocycline reduces cigarette craving in human subjects without severe mental illness The investigators will conduct a two-week randomized double-blind placebo-controlled parallel group pilot study to investigate the effects of minocycline vs placebo on craving and indicators of smoking intensity in smokers with schizophrenia Participants will take minocycline up to 200 mg daily or matching placebo for two weeks Participants will complete cigarette cue-elicited craving platforms and related assessments at baseline and after 1 and 2 weeks of minocycline or placebo treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 4K23DA034034-04 | NIH | None | httpsreporternihgovquickSearch4K23DA034034-04 |