Ignite Creation Date:
2024-05-05 @ 10:55 PM
Last Modification Date:
2024-10-26 @ 10:25 AM
Study NCT ID:
NCT01211418
Status:
COMPLETED
Last Update Posted:
2022-03-14
First Post:
2010-07-28
Brief Title:
Integrative Meditation IM for Cocaine Addiction
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Treatment of Cocaine Addiction With Integrative Meditation
Status:
COMPLETED
Status Verified Date:
2022-02
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:
Cocaine addiction continues to be a major problem in the US with no FDA-approved pharmaceutical therapy Finding effective treatment for cocaine addiction has long been a challenge to scientists and clinicians Psychosocial interventions known as behavior therapies are the cornerstone of cocaine addiction treatment However there is an urgent need to further improve treatment outcomes especially during early recovery and the protracted withdrawal phase of the treatment since many patients drop out or relapse during this phase Our clinical experience and studies suggest that integrative Meditation IM helps reduce cravings and withdrawal symptoms and increases treatment retention The benefit of IM is well supported by tension-reduction theory and attention-networks framework in addiction treatment The proposed study will implement a therapy development study to add IM as a self-care component to the current outpatient treatment of cocaine addiction to improve treatment outcomes
The specific aims of the proposed study include 1 to conduct a 12-week controlled trial with outpatient cocaine users to assess feasibility of recruiting and retaining cocaine addicts and to determine effect size of IM-augmented treatment in comparison with Nondirective Therapy NT control with both groups receiving standard outpatient treatment as usual TAU thereby facilitating future larger scale therapy development study and 2 to examine the changes in attention networks and negative mood as possible mediators of treatment outcomes between the two groups
The specific aims of the proposed study include 1 to conduct a 12-week controlled trial with outpatient cocaine users to assess feasibility of recruiting and retaining cocaine addicts and to determine effect size of IM-augmented treatment in comparison with Nondirective Therapy NT control with both groups receiving standard outpatient treatment as usual TAU thereby facilitating future larger scale therapy development study and 2 to examine the changes in attention networks and negative mood as possible mediators of treatment outcomes between the two groups
Detailed Description:
Randomization Procedure
Subjects who meet DSM-IV cocaine dependence or abuse and other inclusion criteria will be randomly assigned to an IM or NT group using an adaptive urn randomization procedure which adjusts for gender referral source self-referred or count-mandated psychiatric medication yesno and type of cocaine addiction polydrug vs cocaine only Simple randomization may not be adequate to assure a balance between the groups of known predictive indicators While the primary basis of assignment remains randomization urn randomization biases assignment towards balance between groups based on variables known to be related to treatment outcome when sample sizes are intermediate Randomization reduces the possibility that one group will be assigned a disproportionate number of the few patients in certain subgroup
Overview of the Treatment Procedure Twelve treatment sessions over 12 weeks will occur in the outpatient facility once a week about 30 minutes each session Treatment outcomes will be assessed at weeks 4 8 12 and 24 3 months after treatment The follow-up assessments can occur either at the outpatient facility or at our offices in University of Maryland Kernan Hospital We will make the follow-up sessions at both sites equivalent to each other and provide financial compensation for individuals who travel to our campus For those who do not want to come to the University we will ensure that the follow-up sessions at the treatment facility will be held in a private room separate from the location of staff and patients to ensure privacy Subjects are clearly assured that no one at the treatment facility will have access to their treatment outcome data
We considered having the same therapists deliver both treatments to limit therapist-specific effects independent of the actual treatment condition Upon further consideration we decided that this approach could potentially lead to overlap in the delivery of the two treatments andor unintentional biases in the implementation of the control treatment Therefore we decided to have a total of four therapists of similar experience Two will deliver the IM therapy and other two will provide NT The therapists for both groups will have similar qualifications To prevent bias the therapists of NT will be blinded to the study hypotheses Treatment fidelity will be monitored through sample audio records of selected sessions to ensure the separation of treatment protocols If diffusion occurs further training will be utilized To further prevent bias none of the therapists will be involved in outcome assessment and they will be blind to participant responses Assessment measures will be conducted by research staff available for the study
Description of IM Treatment Procedure Basically IM with RFB is a combining transitions behavior therapy designed for different stages of addiction treatment Following three stages and corresponding treatment contents will be included in the 12-week treatment
1 Stage 1 Treatment Engagement and Detoxification week 1-2 In our pilot study some addicts had difficult sitting still for 15-mins meditation with eyes closed but they could do breathing exercise with eyes open In this study we will use 6 breathsminute as near resonant-frequency at the beginning of IM training Each subject will receive a MP3 player with customized RFB guiding program that include waving sound audio and moving bar visual to assist the subject to do RF breathing The subject is required to do abdominal RFB at least 15 min per day open-eye in the first week and close-eye in the second week then gradually switching to a combination of RFB and IM
2 Stage 2 Recovery and transition by reducing craving and irritability week 3-6 Based on prior feedback on RFB from week 3 on therapist will introduce IM technique one by one to the client to practice Week 3 introduce 16-mins IM start with close-eye RFB relaxing body section by section through slow breathing and attention plus breathing to warm up lower abdomen Week 4 RFB IM as a coping tool therapist helps clients find the key trigger situation for stress or relapse and apply RFB and IM technique as a copying strategy Week 5 add guided imagery into IM 21 mins to help detoxify brain and body to learn scan body part by part with increased sensation inside Week 6 review and catch-up if miss any prior sections
3 State 3 Revitalization and Relapse Prevention week 7-12 Through experience of body scan by guided imagery discuss the balance working toward change and accepting experiences that arise Integrate IM techniques into daily life Week 7 customize guided imagery for other problems balance acceptance and change Week 8 introduce full version of IM 25 mins with technique of reversed abdominal breathing which helps recharge the body with vital energy and calmness conclude IM by integrating breath-mind-body into oneness - an optimal level of mind-body integration Week 9 techniques of handling random thoughts during meditation and learn to separate thoughts from action a key issue in dealing with craving or relapse Week 10 how to use IM techniques to handle different relapse triggers do not have to act on thoughts Week 11 different ways to integrate IM technique into daily life make IM part of routine Week 12 review feedback and provide local sources for more meditation practice and study
The success of IM for addiction depends on therapist facilitation and quality of subjects daily practice home-work The description of each facilitation meeting and assigned homework are listed in the therapist manual available upon request In general each session the therapist will 1 get feedback from prior session and daily IM practice 2 teach new components of IM step by step 3 link IM technique to the addiction problem and prevention of relapse
Nondirective Therapy NT for control group NT is a procedure in which the therapist refrains from directing the client but instead reflects back to the client what the latter has said sometimes restating the clients remark NT has been used as a control treatment in previous therapy development studies and was consider a good control in psychotherapy research NT is chosen for this study to control for non-specific effects that show to contribute to outcome such as therapeutic alliance and therapist competency Thus both treatment conditions will contain individual therapy interaction
The protocol for the individualized NT will mirror the layout of IM therapy -12 weekly meetings 30 minutes each Subjects in NT group will be instructed to do Diaphragmatic Breathing DB exercise and will be given assigned homework writing journal and track progress DB is incorporated into the NT as treatment providing non-specific effects associated with attention and homework completion
In short Both IM and NT groups will get the same amount of extra contact with therapist 30 minsweek in addition to their regular treatment with breathing exercise RFB or DB and homework IM or writing journal Both treatment conditions will be audio-taped for evaluation of fidelity and differentiation This design will make the study outcomes more reliable and transferable for the future therapy development studies
Subjects who meet DSM-IV cocaine dependence or abuse and other inclusion criteria will be randomly assigned to an IM or NT group using an adaptive urn randomization procedure which adjusts for gender referral source self-referred or count-mandated psychiatric medication yesno and type of cocaine addiction polydrug vs cocaine only Simple randomization may not be adequate to assure a balance between the groups of known predictive indicators While the primary basis of assignment remains randomization urn randomization biases assignment towards balance between groups based on variables known to be related to treatment outcome when sample sizes are intermediate Randomization reduces the possibility that one group will be assigned a disproportionate number of the few patients in certain subgroup
Overview of the Treatment Procedure Twelve treatment sessions over 12 weeks will occur in the outpatient facility once a week about 30 minutes each session Treatment outcomes will be assessed at weeks 4 8 12 and 24 3 months after treatment The follow-up assessments can occur either at the outpatient facility or at our offices in University of Maryland Kernan Hospital We will make the follow-up sessions at both sites equivalent to each other and provide financial compensation for individuals who travel to our campus For those who do not want to come to the University we will ensure that the follow-up sessions at the treatment facility will be held in a private room separate from the location of staff and patients to ensure privacy Subjects are clearly assured that no one at the treatment facility will have access to their treatment outcome data
We considered having the same therapists deliver both treatments to limit therapist-specific effects independent of the actual treatment condition Upon further consideration we decided that this approach could potentially lead to overlap in the delivery of the two treatments andor unintentional biases in the implementation of the control treatment Therefore we decided to have a total of four therapists of similar experience Two will deliver the IM therapy and other two will provide NT The therapists for both groups will have similar qualifications To prevent bias the therapists of NT will be blinded to the study hypotheses Treatment fidelity will be monitored through sample audio records of selected sessions to ensure the separation of treatment protocols If diffusion occurs further training will be utilized To further prevent bias none of the therapists will be involved in outcome assessment and they will be blind to participant responses Assessment measures will be conducted by research staff available for the study
Description of IM Treatment Procedure Basically IM with RFB is a combining transitions behavior therapy designed for different stages of addiction treatment Following three stages and corresponding treatment contents will be included in the 12-week treatment
1 Stage 1 Treatment Engagement and Detoxification week 1-2 In our pilot study some addicts had difficult sitting still for 15-mins meditation with eyes closed but they could do breathing exercise with eyes open In this study we will use 6 breathsminute as near resonant-frequency at the beginning of IM training Each subject will receive a MP3 player with customized RFB guiding program that include waving sound audio and moving bar visual to assist the subject to do RF breathing The subject is required to do abdominal RFB at least 15 min per day open-eye in the first week and close-eye in the second week then gradually switching to a combination of RFB and IM
2 Stage 2 Recovery and transition by reducing craving and irritability week 3-6 Based on prior feedback on RFB from week 3 on therapist will introduce IM technique one by one to the client to practice Week 3 introduce 16-mins IM start with close-eye RFB relaxing body section by section through slow breathing and attention plus breathing to warm up lower abdomen Week 4 RFB IM as a coping tool therapist helps clients find the key trigger situation for stress or relapse and apply RFB and IM technique as a copying strategy Week 5 add guided imagery into IM 21 mins to help detoxify brain and body to learn scan body part by part with increased sensation inside Week 6 review and catch-up if miss any prior sections
3 State 3 Revitalization and Relapse Prevention week 7-12 Through experience of body scan by guided imagery discuss the balance working toward change and accepting experiences that arise Integrate IM techniques into daily life Week 7 customize guided imagery for other problems balance acceptance and change Week 8 introduce full version of IM 25 mins with technique of reversed abdominal breathing which helps recharge the body with vital energy and calmness conclude IM by integrating breath-mind-body into oneness - an optimal level of mind-body integration Week 9 techniques of handling random thoughts during meditation and learn to separate thoughts from action a key issue in dealing with craving or relapse Week 10 how to use IM techniques to handle different relapse triggers do not have to act on thoughts Week 11 different ways to integrate IM technique into daily life make IM part of routine Week 12 review feedback and provide local sources for more meditation practice and study
The success of IM for addiction depends on therapist facilitation and quality of subjects daily practice home-work The description of each facilitation meeting and assigned homework are listed in the therapist manual available upon request In general each session the therapist will 1 get feedback from prior session and daily IM practice 2 teach new components of IM step by step 3 link IM technique to the addiction problem and prevention of relapse
Nondirective Therapy NT for control group NT is a procedure in which the therapist refrains from directing the client but instead reflects back to the client what the latter has said sometimes restating the clients remark NT has been used as a control treatment in previous therapy development studies and was consider a good control in psychotherapy research NT is chosen for this study to control for non-specific effects that show to contribute to outcome such as therapeutic alliance and therapist competency Thus both treatment conditions will contain individual therapy interaction
The protocol for the individualized NT will mirror the layout of IM therapy -12 weekly meetings 30 minutes each Subjects in NT group will be instructed to do Diaphragmatic Breathing DB exercise and will be given assigned homework writing journal and track progress DB is incorporated into the NT as treatment providing non-specific effects associated with attention and homework completion
In short Both IM and NT groups will get the same amount of extra contact with therapist 30 minsweek in addition to their regular treatment with breathing exercise RFB or DB and homework IM or writing journal Both treatment conditions will be audio-taped for evaluation of fidelity and differentiation This design will make the study outcomes more reliable and transferable for the future therapy development studies
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 |
|---|---|---|---|
| R21DA025149 | NIH | None | httpsreporternihgovquickSearchR21DA025149 |