Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT01211418 |
| Other study ID # |
HP-00040827 |
| Secondary ID |
R21DA025149 |
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 2009 |
| Est. completion date |
March 2012 |
Study information
| Verified date |
February 2022 |
| Source |
University of Maryland, Baltimore |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Cocaine addiction continues to be a major problem in the U.S. 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.
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
(yes/no), 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
and/or 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 breaths/minute
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 subject's
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 client's 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
mins/week) 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.
