Opiate DependencePhase 1NCT00439036
Acceptance Therapy During Methadone Detoxification
A Phase 1 study testing Behavior Therapy and Drug Counseling in people with Opiate Dependence, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
The purpose of this study is to develop an opiate detoxification behavior therapy based on current Acceptance and Commitment Therapy (ACT) theory and method, and to test its feasibility and promise in the context of voluntary methadone detoxification. Read more about this study
- Who is it for?
- Ages 25 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Opiate Dependence
- What is being tested?
- Behavior Therapy and Drug Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2006to Dec 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Ages 25 through 60
- Dependent upon opiates (heroin/methadone) according to DSM-IV criteria
- Using heroin/methadone for at least 5 years
- Endorse 7 or higher on a 10-point motivation for opiate detoxification item
- In good physical and psychiatric health
- Able to read, speak, and understand English
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- Willing and able to meet study requirements
- Willing to participate in the 1 month follow up session
- Able to provide the name of at least one person who can generally locate them
- Attending a licensed methadone clinic regularly with opiate (other than methadone) negative urine screens in the past month.
- Intake screen negative for opiates (other than methadone)
- >110 lbs \& body mass index between 18 and 28 kg/m2
Who cannot join
- Younger than 25 and older than 60 years of age
- Current dependence on other substances
- Severe medical, cognitive, and/or psychiatric impairment that precludes cooperation with study protocol
- Current and severe psychiatric symptoms requiring medical attention
- Current substance withdrawal symptoms requiring medical attention
- Unable to read, speak, and understand English
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- Unwillingness of women of child bearing age to use contraception
- Currently receiving other psychosocial therapy for substance abuse (12-step meetings are ok)
- Impending incarceration
- Unable or unwilling to meet study requirements, including provision of signed consent
- Less than 7 on a 10-point motivation for opiate detoxification scale
- no documentation of monitored methadone use
- non-methadone opiate positive urine screen in the past month according to self-report
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Medical School- Houston; Department of Psychiatry; Mental Sciences Institute
Houston, Texas, 77030
About this study
The purpose of this study is to develop an opiate detoxification behavior therapy based on current Acceptance and Commitment Therapy (ACT) theory and method, and to test its feasibility and promise in the context of voluntary methadone detoxification.
Read the detailed description
This Stage I pilot study will employ a randomized, controlled, between groups design in which 70 opiate dependent patients seeking methadone detoxification will be randomized into one of two treatment conditions: ACT opiate detoxification therapy or Drug Counseling. Both therapies will be delivered in the context of a 5-month methadone dose reduction based on a linear dosing strategy. Efficacy variables will include: (1) abstinence rates during and 1-month after detoxification as assessed by regular urine screens; (2) retention of patients in treatment; and (3) patient satisfaction and treatment acceptability. Reduction in HIV/Hepatitis C risk behaviors and changes in psychosocial functioning (e.g., employment, family, legal) will also be explored, along with mediators/moderators of the therapy (i.e., experiential avoidance). Subjects will be recruited from Houston area methadone clinics and the general community via advertising and will receive methadone as part of this protocol. A 2-4 week stabilization period will precede the 5-month methadone dose reduction. During the dose reduction, participants will attend the clinic twice each week and will receive weekly therapy. Participants will be contacted for follow up assessments up to one month post treatment.
- Conditions
- Opiate Dependence
- Being tested
- Behavior Therapy, Drug Counseling
- Keywords
- Opiate, Behavior Therapy, Methadone, Acceptance and Commitment Therapy (ACT)
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavior TherapyBehavioural
The Act-ODT intervention will consist of 24 50-minute sessions delivered weekly in the context of a methadone dose reduction program. Sessions will begin during the methadone run-up/stabilization period approximately 4 weeks prior to the onset of dose reduction and will continue through the 20 week detoxification.
Drug CounselingBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Behavior Therapy: Acceptance and Commitment Therapy | Experimental | The Act-ODT intervention consists of 24 50-minute sessions delivered weekly in the context of a methadone dose reduction program. Sessions will begin during the methadone run-up/stabilization period approximately 4 weeks prior to the onset of dose reduction and will continue through the 20 week detoxification.
-------------------------------------------------------------------------------- Receives: Behavioral: Behavior Therapy |
| Drug Counseling | Active comparator | The Drug Counseling intervention consists of 24 50-minute sessions delivered weekly in the context of a methadone dose reduction program. Sessions will begin during the methadone run-up/stabilization period approximately 4 weeks prior to the onset of dose reduction and will continue through the 20 week detoxification. Receives: Behavioral: Drug Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Substance use
Measured: Baseline, twice a week, end of study, one month after the study, 6 months after the study
HIV/HCV risk behaviors
Measured: Intake, week 9, week 19
Secondary outcomes (4)
Retention
Measured: twice a week
Client adherence
Measured: twice a week
Psychosocial functioning
Measured: baseline and once a month
Treatment satisfaction
Measured: once a month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2007 (estimated)
- Study startJul 2006
- Primary completionAug 2010
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opiate DependenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center, Houston
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Angela Stotts, The University of Texas Health Science Center, Houston
- Investigators
- Angela L Stotts, Ph.D., Principal investigator, Associate Professor- University of Texas Houston Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00439036
- Sponsor's protocol ID
- DA019436-01
- Other IDs
- R01DA019436-01, DCNBR
- Status last verified
- May 2013
- First submitted
- 21 Feb 2007
- Last updated
- 6 May 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acceptance Therapy During Methadone Detoxification
- ClinicalTrials.gov ID
- NCT00439036
- Acronym / sponsor ID
- DA019436-01
- Conditions
- Opiate Dependence
- Keywords
- Opiate, Behavior Therapy, Methadone, Acceptance and Commitment Therapy (ACT)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Jul 2006
- Primary completion
- Aug 2010 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 22 Feb 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to develop an opiate detoxification behavior therapy based on current Acceptance and Commitment Therapy (ACT) theory and method, and to test its feasibility and promise in the context of voluntary methadone detoxification.
Detailed description
This Stage I pilot study will employ a randomized, controlled, between groups design in which 70 opiate dependent patients seeking methadone detoxification will be randomized into one of two treatment conditions: ACT opiate detoxification therapy or Drug Counseling. Both therapies will be delivered in the context of a 5-month methadone dose reduction based on a linear dosing strategy. Efficacy variables will include: (1) abstinence rates during and 1-month after detoxification as assessed by regular urine screens; (2) retention of patients in treatment; and (3) patient satisfaction and treatment acceptability. Reduction in HIV/Hepatitis C risk behaviors and changes in psychosocial functioning (e.g., employment, family, legal) will also be explored, along with mediators/moderators of the therapy (i.e., experiential avoidance). Subjects will be recruited from Houston area methadone clinics and the general community via advertising and will receive methadone as part of this protocol. A 2-4 week stabilization period will precede the 5-month methadone dose reduction. During the dose reduction, participants will attend the clinic twice each week and will receive weekly therapy. Participants will be contacted for follow up assessments up to one month post treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Behavior Therapy: Acceptance and Commitment Therapy | Experimental | Behavioral: Behavior TherapyThe Act-ODT intervention consists of 24 50-minute sessions delivered weekly in the context of a methadone dose reduction program. Sessions will begin during the methadone run-up/stabilization period approximately 4 weeks prior to the onset of dose reduction and will continue through the 20 week detoxification. -------------------------------------------------------------------------------- |
| Drug Counseling | Active comparator | Behavioral: Drug CounselingThe Drug Counseling intervention consists of 24 50-minute sessions delivered weekly in the context of a methadone dose reduction program. Sessions will begin during the methadone run-up/stabilization period approximately 4 weeks prior to the onset of dose reduction and will continue through the 20 week detoxification. |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Ages 25 through 60
- Dependent upon opiates (heroin/methadone) according to DSM-IV criteria
- Using heroin/methadone for at least 5 years
- Endorse 7 or higher on a 10-point motivation for opiate detoxification item
- In good physical and psychiatric health
Key exclusion criteria (13 listed)
- Younger than 25 and older than 60 years of age
- Current dependence on other substances
- Severe medical, cognitive, and/or psychiatric impairment that precludes cooperation with study protocol
- Current and severe psychiatric symptoms requiring medical attention
- Current substance withdrawal symptoms requiring medical attention
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behavior TherapyThe Act-ODT intervention will consist of 24 50-minute sessions delivered weekly in the context of a methadone dose reduction program. Sessions will begin during the methadone run-up/stabilization period approximately 4 weeks prior to the onset of dose reduction and will continue through the 20 week detoxification. | Behavioural | Behavior Therapy: Acceptance and Commitment Therapy |
| Drug Counseling | Behavioural | Drug Counseling |
Primary outcome
Substance use
Time frame: Baseline, twice a week, end of study, one month after the study, 6 months after the study
HIV/HCV risk behaviors
Time frame: Intake, week 9, week 19
4 secondary outcomes
Retention
Time frame: twice a week
Client adherence
Time frame: twice a week
Psychosocial functioning
Time frame: baseline and once a month
Treatment satisfaction
Time frame: once a month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Angela L Stotts, Ph.D. principal investigator
Associate Professor- University of Texas Houston Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Behavior Therapy and Drug Counseling in people with Opiate Dependence, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Substance use (time frame: Baseline, twice a week, end of study, one month after the study, 6 months after the study). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2013.