Ignite Creation Date:
2024-05-06 @ 12:50 AM
Last Modification Date:
2024-10-26 @ 10:56 AM
Study NCT ID:
NCT01678833
Status:
COMPLETED
Last Update Posted:
2018-04-05
First Post:
2012-08-31
Brief Title:
Understanding Drug Abuse Treatment Outcomes
Sponsor:
National Institute on Drug Abuse NIDA
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Neural Mechanistic Explanations for Differential Drug Abuse Treatment Outcomes
Status:
COMPLETED
Status Verified Date:
2016-03-07
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
Although some treatments for substance abuse are considered effective for some people who are drug dependent many others do not benefit as much over time Researchers are working to find out what characteristics predict treatment response They also want to determine how to design treatments that are more effective for a greater number of substance abusers This pilot study involves providing drug addicts with cognitive behavioral therapy CBT a treatment considered to be one of the most effective in reducing substance-abuse to identify ways in which the brain works that may predict and explain treatment effects A comparison group will be included that receives only standard psychotherapy or talk therapy This approach will enable researchers to determine what factors might be interfering with favorable treatment outcomes and how to refine or develop new treatments that work well for more people
Objectives
- To identify individual characteristics which predict and explain the effects of CBT in people with opiate dependence
Eligibility
Males between 18 and 60 years of age who are dependent on opioids such as heroin
Participants must be willing to take buprenorphine and receive substance abuse counseling
Design
Participants will be screened with a physical exam and medical history
Researchers will ask questions about participants ability to cope in certain situations along with questions about drug use and lifestyle issues These questions will be asked twice before and after completing treatment
Participants will be placed into one of two groups One group will have CBT twice a week for 8 weeks The other group will have standard counseling twice per week Both groups will take buprenorphine as part of the drug abuse treatment
Participants will have other tests during this study They will have imaging studies to look at brain function These studies will test thinking and decision making
Although some treatments for substance abuse are considered effective for some people who are drug dependent many others do not benefit as much over time Researchers are working to find out what characteristics predict treatment response They also want to determine how to design treatments that are more effective for a greater number of substance abusers This pilot study involves providing drug addicts with cognitive behavioral therapy CBT a treatment considered to be one of the most effective in reducing substance-abuse to identify ways in which the brain works that may predict and explain treatment effects A comparison group will be included that receives only standard psychotherapy or talk therapy This approach will enable researchers to determine what factors might be interfering with favorable treatment outcomes and how to refine or develop new treatments that work well for more people
Objectives
- To identify individual characteristics which predict and explain the effects of CBT in people with opiate dependence
Eligibility
Males between 18 and 60 years of age who are dependent on opioids such as heroin
Participants must be willing to take buprenorphine and receive substance abuse counseling
Design
Participants will be screened with a physical exam and medical history
Researchers will ask questions about participants ability to cope in certain situations along with questions about drug use and lifestyle issues These questions will be asked twice before and after completing treatment
Participants will be placed into one of two groups One group will have CBT twice a week for 8 weeks The other group will have standard counseling twice per week Both groups will take buprenorphine as part of the drug abuse treatment
Participants will have other tests during this study They will have imaging studies to look at brain function These studies will test thinking and decision making
Detailed Description:
OBJECTIVE
The primary objective of this pilot study is to collect data for a NIH RO1 grant submission that aims to elucidate cognitive emotional regulatory and neurobiological mechanisms that both moderate and mediate effects of cognitive behavioral therapy CBT in individuals with opiate dependence CBT has proven moderately effective in treating substance abuse however significant variability in treatment outcomes remains CBT curricula teach adaptive decision making and cognitive reappraisal skills to down-regulate emotional responses to drug-related cues thereby promoting avoidance of drug use situations A certain level of cognitive and emotion regulatory functioning is however required for assimilating and executing these skills which is often deficient in substance abusers Consequently many addicts cannot effectively process and act on CBT curriculum leading to poor treatment outcomes Tailoring interventions requires systematic investigation of neurobiological indicators that interfere with or promote favorable treatment responsivity
The small pilot study outlined below will provide the feasibility and supportive data for a larger effort
Aim 1 Moderation Identify baseline ECF and emotion regulatory functions and their neural substrates that predict treatment variability in the form of a program responsivity eg treatment engagement motivation social competences and b posttreatment outcomes eg substance use frequency days of continuous abstinence Functional magnetic resonance imaging fMRI will be used during performance of tasks that measure ECF decision-making inhibitory control and cognitive reappraisal of emotional cues to investigate the neuromodulatory role of PFC regions eg OFC ACC on emotion eg amygdala and reward eg ventral striatum structures and autonomic activity
Aim 2 Mediation Determine whether change in these neurocognitive functions in response to CBT mediate intervention effects Evidence suggests that CBT alters PFC and limbic function such changes are associated with clinical outcomes in depression and anxiety Similarly in drug abusers we predict treatment response will be associated with changes in neural activation patterns ECF and emotional regulation and that little to no change will occur in those with relatively poorer outcomes
Study Population Participants will be 18 primary opioid dependent individuals between the ages of 18 and 60 These individuals will either be enrolled in NIDA Protocol 09-DA-N020 Dr Kenzie Preston PI or patients at the University of Maryland Medical Center outpatient substance abuse clinics ie Alcohol and Drug Abuse Program ADAP or Outpatient Addiction Treatment Service OATS and are receiving buprenorphine
DESIGN
Study participants visit their treatment facility daily for buprenorphine and receive standard counseling as part of Protocol 09-DA-N020 or their treatment protocol at ADAP or
OATS They will be screened by MMG for eligibility into the present study then randomly assigned to a TAU control group or a CBT group This study consists of 3 assessment time points baseline midway post-treatment and 16 bi-weekly counseling visits CBT or standard TAU counseling Baseline assessments will consist of functional magnetic resonance imaging fMRI during performance of decision making inhibitory control and emotional regulatory tasks Questionnaires will be used to evaluate historical and current drug use background and psychological traits and other relevant factors Those in the TAU group visit their treatment facility routinely for buprenorphine and standard counseling but will not receive CBT The CBT group participants will undergo 8 weeks of CBT in the
Archway Clinic twice a week provided by a CBT clinician from Mountain Manor Treatment
Center who will be supervised by Dr Marc Fishman treatment director at MMTC this CBT counseling will be in place of the TAU counseling they would be receiving as part of the parent protocol Midway through CBTTAU counseling participants in this pilot study will be evaluated outside the scanner with the same cognitive tasks used in the scanner and questionnaires from baseline After treatment completion they will receive a post-treatment fMRI scan where they will perform the same tasks and questionnaires Also we will preliminarily assess mediation by examining variability in level of responsivity within the treatment group to determine whether this outcome is related to functional baseline characteristics and change over time Expectations are that baseline features will predict intervention response and that these same characteristics will change over time in response to intervention in those with favorable outcomes
OUTCOME MEASURES
The focus of our outcome evaluation will be use of opioid eg frequency days of continuous abstinence etc coping strategies and change in lifestyle measures eg employment relationships behavioral problems treatment engagement
The primary objective of this pilot study is to collect data for a NIH RO1 grant submission that aims to elucidate cognitive emotional regulatory and neurobiological mechanisms that both moderate and mediate effects of cognitive behavioral therapy CBT in individuals with opiate dependence CBT has proven moderately effective in treating substance abuse however significant variability in treatment outcomes remains CBT curricula teach adaptive decision making and cognitive reappraisal skills to down-regulate emotional responses to drug-related cues thereby promoting avoidance of drug use situations A certain level of cognitive and emotion regulatory functioning is however required for assimilating and executing these skills which is often deficient in substance abusers Consequently many addicts cannot effectively process and act on CBT curriculum leading to poor treatment outcomes Tailoring interventions requires systematic investigation of neurobiological indicators that interfere with or promote favorable treatment responsivity
The small pilot study outlined below will provide the feasibility and supportive data for a larger effort
Aim 1 Moderation Identify baseline ECF and emotion regulatory functions and their neural substrates that predict treatment variability in the form of a program responsivity eg treatment engagement motivation social competences and b posttreatment outcomes eg substance use frequency days of continuous abstinence Functional magnetic resonance imaging fMRI will be used during performance of tasks that measure ECF decision-making inhibitory control and cognitive reappraisal of emotional cues to investigate the neuromodulatory role of PFC regions eg OFC ACC on emotion eg amygdala and reward eg ventral striatum structures and autonomic activity
Aim 2 Mediation Determine whether change in these neurocognitive functions in response to CBT mediate intervention effects Evidence suggests that CBT alters PFC and limbic function such changes are associated with clinical outcomes in depression and anxiety Similarly in drug abusers we predict treatment response will be associated with changes in neural activation patterns ECF and emotional regulation and that little to no change will occur in those with relatively poorer outcomes
Study Population Participants will be 18 primary opioid dependent individuals between the ages of 18 and 60 These individuals will either be enrolled in NIDA Protocol 09-DA-N020 Dr Kenzie Preston PI or patients at the University of Maryland Medical Center outpatient substance abuse clinics ie Alcohol and Drug Abuse Program ADAP or Outpatient Addiction Treatment Service OATS and are receiving buprenorphine
DESIGN
Study participants visit their treatment facility daily for buprenorphine and receive standard counseling as part of Protocol 09-DA-N020 or their treatment protocol at ADAP or
OATS They will be screened by MMG for eligibility into the present study then randomly assigned to a TAU control group or a CBT group This study consists of 3 assessment time points baseline midway post-treatment and 16 bi-weekly counseling visits CBT or standard TAU counseling Baseline assessments will consist of functional magnetic resonance imaging fMRI during performance of decision making inhibitory control and emotional regulatory tasks Questionnaires will be used to evaluate historical and current drug use background and psychological traits and other relevant factors Those in the TAU group visit their treatment facility routinely for buprenorphine and standard counseling but will not receive CBT The CBT group participants will undergo 8 weeks of CBT in the
Archway Clinic twice a week provided by a CBT clinician from Mountain Manor Treatment
Center who will be supervised by Dr Marc Fishman treatment director at MMTC this CBT counseling will be in place of the TAU counseling they would be receiving as part of the parent protocol Midway through CBTTAU counseling participants in this pilot study will be evaluated outside the scanner with the same cognitive tasks used in the scanner and questionnaires from baseline After treatment completion they will receive a post-treatment fMRI scan where they will perform the same tasks and questionnaires Also we will preliminarily assess mediation by examining variability in level of responsivity within the treatment group to determine whether this outcome is related to functional baseline characteristics and change over time Expectations are that baseline features will predict intervention response and that these same characteristics will change over time in response to intervention in those with favorable outcomes
OUTCOME MEASURES
The focus of our outcome evaluation will be use of opioid eg frequency days of continuous abstinence etc coping strategies and change in lifestyle measures eg employment relationships behavioral problems treatment engagement
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 |
|---|---|---|---|
| 12-DA-N480 | None | None | None |