Ignite Creation Date:
2024-05-05 @ 4:46 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00318760
Status:
COMPLETED
Last Update Posted:
2018-04-05
First Post:
2006-04-25
Brief Title:
Effect of Clonidine on Responses to Imagery Scripts
Sponsor:
National Institute on Drug Abuse NIDA
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Effect of Clonidine on Responses to Imagery Scripts
Status:
COMPLETED
Status Verified Date:
2014-07-08
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:
Background
- Research has shown that clonidine a drug originally prescribed to treat high blood pressure and some symptoms of opioid withdrawal can help block stress-induced relapse to heroin and cocaine seeking in rats However it does not seem to block cue-induced relapse in rats Researchers are interested in studying whether clonidine shows the same pattern of effects on stress- and cue-induced cravings for heroin or cocaine in humans
Objectives
- To compare the ability of clonidine to reduce stress- and cue-induced cocaine and heroin craving in drug abusers
Eligibility
- Individuals between 18 and 55 years of age who are current cocaine or heroin users
Design
This study will consist of two visits a screening visit to determine eligibility and an experimentalscript session
Before the script session participants will provide urine and breath samples for testing Participants will complete questionnaires to measure their current drug craving and days since last use of cocaine or heroin
At the start of the script session participants will receive a dose of clonidine or placebo as directed by the study researchers Three hours after dosing participants will be read four scripts two neutral one stress-inducing and one drug-cue-related with breaks in between each script After each script participants will respond to questions about levels of stress and craving
Participants will provide saliva samples immediately before and during the script readings and will also be measured for skin response to the scripts
- Research has shown that clonidine a drug originally prescribed to treat high blood pressure and some symptoms of opioid withdrawal can help block stress-induced relapse to heroin and cocaine seeking in rats However it does not seem to block cue-induced relapse in rats Researchers are interested in studying whether clonidine shows the same pattern of effects on stress- and cue-induced cravings for heroin or cocaine in humans
Objectives
- To compare the ability of clonidine to reduce stress- and cue-induced cocaine and heroin craving in drug abusers
Eligibility
- Individuals between 18 and 55 years of age who are current cocaine or heroin users
Design
This study will consist of two visits a screening visit to determine eligibility and an experimentalscript session
Before the script session participants will provide urine and breath samples for testing Participants will complete questionnaires to measure their current drug craving and days since last use of cocaine or heroin
At the start of the script session participants will receive a dose of clonidine or placebo as directed by the study researchers Three hours after dosing participants will be read four scripts two neutral one stress-inducing and one drug-cue-related with breaks in between each script After each script participants will respond to questions about levels of stress and craving
Participants will provide saliva samples immediately before and during the script readings and will also be measured for skin response to the scripts
Detailed Description:
Background Stress and exposure to drug-related cues environmental stimuli previously associated with drug availability are considered factors that increase the risk of relapse to heroin andor cocaine use The two factors may act through different neural mechanisms Alpha-2 adrenergic agonists such as clonidine have been shown to block stress-induced relapse but not cue-induced relapse to heroin and cocaine self-administration in rodents The ability of clonidine to attenuate stress- or cue-induced heroin and cocaine craving in drug abusers has not been tested It is important to determine in humans whether clonidine blocks the acute effects of only one putative class of relapse precipitants or whether its effects are more general
Scientific goal To compare the ability of clonidine to reduce stress-induced and cue-induced cocaine and heroin craving in drug abusers
Participant population A total of up to 160 drug abusers using cocaine heroin or both will be enrolled Target enrollment will include 40 women and 60 minorities mostly African-American
Experimental design and methods Participants will be randomized to one of three groups receiving clonidine 01 mg clonidine 02 mg or placebo orally under double-blind conditions The study will consist of a single 5-6 hr experimental session in which there will be baseline measures drug administration and four script-guided imagery sets each followed by a period of data collection Three hours after dosing when peak plasma clonidine concentrations are reached participants will be exposed to four scripts one stress-inducing one describing drug cues and two with neutral content The standardized script-guided imagery procedure has previously been shown to reliably induce negative affective states stress scripts andor craving stress and drug-cue scripts compared to the neutral scripts and to have internal and external validity Tiffany and Drobes 1990 Maude-Griffin and Tiffany 1996 Taylor et al 2000 Sinha et al 1999 2000 2003 Singleton et al 2003 Tiffany and Haekeneworth 1991 Elash et al 1995 Drobes and Tiffany 1997 Taylor et al 2000 Singleton et al 2003 Outcome measures will include subjective ratings of drug craving and mood autonomic response galvanic skin response GSR and endocrine responses salivary cortisol and salivary -amylase a measure of endogenous adrenergic activity during stress Chatterton et al 1996 Nater et al 2005 van Stegeren et al 2005
Benefits to participants andor society There are no direct benefits to participants However if clonidine is effective in blocking stress-induced andor cue-induced craving then the results will be used as a basis for designing a treatment trial and drug abusers and society may benefit from the eventual use of clonidine or other alpha agonists for prevention of relapse in cocaine and heroin users In addition this research will provide information on the clinical relevance of a preclinical model of relapse possibly strengthening arguments for its use in medication development
Risks to participants Participants may experience side effects from clonidine such as sedation and are expected to experience brief mild psychological stress and drug craving from the laboratory script procedures Prior to leaving the session participants will be assessed for the presence of continued drug effects If participants are experiencing any stress or craving at the end of the session they will undergo a 10-minute guided relaxation session which will be repeated until feelings of stress or craving dissipate before being released from the laboratory Participants may be kept longer than the planned session length up to and including staying overnight on the inpatient ward because of continued side effects or elevated stress or craving If the MRP deems it medically necessary participants will be sent to JHBMC emergency department for further evaluation and treatment
Scientific goal To compare the ability of clonidine to reduce stress-induced and cue-induced cocaine and heroin craving in drug abusers
Participant population A total of up to 160 drug abusers using cocaine heroin or both will be enrolled Target enrollment will include 40 women and 60 minorities mostly African-American
Experimental design and methods Participants will be randomized to one of three groups receiving clonidine 01 mg clonidine 02 mg or placebo orally under double-blind conditions The study will consist of a single 5-6 hr experimental session in which there will be baseline measures drug administration and four script-guided imagery sets each followed by a period of data collection Three hours after dosing when peak plasma clonidine concentrations are reached participants will be exposed to four scripts one stress-inducing one describing drug cues and two with neutral content The standardized script-guided imagery procedure has previously been shown to reliably induce negative affective states stress scripts andor craving stress and drug-cue scripts compared to the neutral scripts and to have internal and external validity Tiffany and Drobes 1990 Maude-Griffin and Tiffany 1996 Taylor et al 2000 Sinha et al 1999 2000 2003 Singleton et al 2003 Tiffany and Haekeneworth 1991 Elash et al 1995 Drobes and Tiffany 1997 Taylor et al 2000 Singleton et al 2003 Outcome measures will include subjective ratings of drug craving and mood autonomic response galvanic skin response GSR and endocrine responses salivary cortisol and salivary -amylase a measure of endogenous adrenergic activity during stress Chatterton et al 1996 Nater et al 2005 van Stegeren et al 2005
Benefits to participants andor society There are no direct benefits to participants However if clonidine is effective in blocking stress-induced andor cue-induced craving then the results will be used as a basis for designing a treatment trial and drug abusers and society may benefit from the eventual use of clonidine or other alpha agonists for prevention of relapse in cocaine and heroin users In addition this research will provide information on the clinical relevance of a preclinical model of relapse possibly strengthening arguments for its use in medication development
Risks to participants Participants may experience side effects from clonidine such as sedation and are expected to experience brief mild psychological stress and drug craving from the laboratory script procedures Prior to leaving the session participants will be assessed for the presence of continued drug effects If participants are experiencing any stress or craving at the end of the session they will undergo a 10-minute guided relaxation session which will be repeated until feelings of stress or craving dissipate before being released from the laboratory Participants may be kept longer than the planned session length up to and including staying overnight on the inpatient ward because of continued side effects or elevated stress or craving If the MRP deems it medically necessary participants will be sent to JHBMC emergency department for further evaluation and treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 05-DA-N403 | None | None | None |