AlcoholismPhase 2ATIVRNCT00132795
Using Telephone Technology to Prevent Relapse After Alcoholism Treatment
A Phase 2 study testing Daily monitoring of alcohol & drug use, & therapy skills in people with Alcoholism, run by University of Vermont at 1 site in United States.
Trial summary
The purpose of this study is to determine whether a telephone based self-help program will prevent relapse among individuals undergoing standard substance abuse treatment. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Alcoholism
- What is being tested?
- Daily monitoring of alcohol & drug use, & therapy skills
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 158 participants
- Where
- 1 siteUnited States
- Study dates
- May 2005to Jul 2010
- Phase
- Phase 2
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meets current DSM-IV criteria for alcohol dependence
- Active drinking during the three months prior to entry into treatment
- Minimum age of 19
- Minimum sixth grade reading level.
Who cannot join
- Meets criteria for a current psychotic illness
- Imminent plans to move or be incarcerated
- Presence of such severe hearing, visual, or cognitive deficit(s) that participation in CBT or use of an Interactive Voice Response (IVR) system are not possible
- Inability to identify at least one "locator" person to assist in tracking for follow-up assessments
- Does not have telephone service within the home
- Incarceration while in active protocol in the study
- Attendance of less than 8 of 12 CBT sessions
Trial locations and contacts
1 site in 1 country.
United States1 site
UVM Health Behavior Research Center
Burlington, Vermont, 05403
About this study
Official title: Therapeutic IVR to Augment CBT in Alcohol Dependence
The purpose of this study is to determine whether a telephone based self-help program will prevent relapse among individuals undergoing standard substance abuse treatment.
Read the detailed description
Relapse rates in the first few months following substance abuse treatment are as high as 50%, in spite of the immediate effectiveness of treatments such as Cognitive Behavioral Therapy (CBT). Continuing use of therapy skills following treatment is associated with maintenance of treatment gains. We have programmed a telephone to deliver pre-recorded summaries and rehearsal sessions of skills learned in therapy. The system also includes monthly feedback messages from therapists. We expect that this ad-lib access to therapy skills would allow patients to generalize skills to their personal post-treatment lives. It would also allow individuals in remote or rural areas to obtain access to assistance without travel barriers.
Comparison(s): patients completing group CBT for substance abuse will be randomly assigned to two conditions. In one condition, patients will have unlimited access to the therapeutic telephone system for 4 months. The other condition is standard care (i.e., no formal relapse prevention).
- Conditions
- Alcoholism
- Being tested
- Daily monitoring of alcohol & drug use, & therapy skills, control group
- Keywords
- Cognitive Therapy, Recurrence, Prevention, Educational Technology
- Medical subject headings
- Alcoholism, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Daily monitoring of alcohol & drug use, & therapy skillsBehavioural
Also called relapse prevention
Comparison(s): patients completing group CBT for substance abuse will be randomly assigned to two conditions. In one condition, patients will have unlimited access to the therapeutic telephone system for 4 months. The other condition is standard care (i.e., no formal relapse prevention).
control groupBehavioural
standard care (no added treatment)
| Study group | Role | What they receive |
|---|---|---|
| 1 Therapeutic Phone System | Experimental | patients assigned to this condition will have unlimited access to the therapeutic telephone system for 4 months. Receives: Behavioral: Daily monitoring of alcohol & drug use, & therapy skills |
| 2 Standard care | Active comparator | Standard post-CBT care (i.e., no formal relapse prevention or professional treatment). Receives: Behavioral: control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of alcohol and use
drinks per day, drinks per drinking day, percent days abstinent, heavy drinking days
Measured: 4 months and one year
Secondary outcomes (1)
Utilization of the telephone system components during the study
call rate, access of coping skills reviews and practices, access of monthly messages.
Measured: 4 months and one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2005 (estimated)
- Study startMay 2005
- Primary completionDec 2009
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AlcoholismStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 158 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Vermont
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, John E. Helzer, MD, University of Vermont
- Investigators
- John E. Helzer, MD, Principal investigator, University of Vermont
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00132795
- Sponsor's protocol ID
- NIAAAHEL014270
- Other IDs
- R01AA014270
- Acronym
- ATIVR
- Status last verified
- Jun 2012
- First submitted
- 19 Aug 2005
- Last updated
- 21 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic IVR to Augment CBT in Alcohol Dependence
- ClinicalTrials.gov ID
- NCT00132795
- Acronym / sponsor ID
- ATIVR / NIAAAHEL014270
- Conditions
- Alcoholism
- Keywords
- Cognitive Therapy, Recurrence, Prevention, Educational Technology
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 158 participants (actual)
- Lead sponsor
- University of VermontUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- May 2005
- Primary completion
- Dec 2009 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 22 Aug 2005 (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 determine whether a telephone based self-help program will prevent relapse among individuals undergoing standard substance abuse treatment.
Detailed description
Relapse rates in the first few months following substance abuse treatment are as high as 50%, in spite of the immediate effectiveness of treatments such as Cognitive Behavioral Therapy (CBT). Continuing use of therapy skills following treatment is associated with maintenance of treatment gains. We have programmed a telephone to deliver pre-recorded summaries and rehearsal sessions of skills learned in therapy. The system also includes monthly feedback messages from therapists. We expect that this ad-lib access to therapy skills would allow patients to generalize skills to their personal post-treatment lives. It would also allow individuals in remote or rural areas to obtain access to assistance without travel barriers.
Comparison(s): patients completing group CBT for substance abuse will be randomly assigned to two conditions. In one condition, patients will have unlimited access to the therapeutic telephone system for 4 months. The other condition is standard care (i.e., no formal relapse prevention).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 Therapeutic Phone System | Experimental | Behavioral: Daily monitoring of alcohol & drug use, & therapy skillspatients assigned to this condition will have unlimited access to the therapeutic telephone system for 4 months. |
| 2 Standard care | Active comparator | Behavioral: control groupStandard post-CBT care (i.e., no formal relapse prevention or professional treatment). |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Meets current DSM-IV criteria for alcohol dependence
- Active drinking during the three months prior to entry into treatment
- Minimum age of 19
- Minimum sixth grade reading level.
Key exclusion criteria (7 listed)
- Meets criteria for a current psychotic illness
- Imminent plans to move or be incarcerated
- Presence of such severe hearing, visual, or cognitive deficit(s) that participation in CBT or use of an Interactive Voice Response (IVR) system are not possible
- Inability to identify at least one "locator" person to assist in tracking for follow-up assessments
- Does not have telephone service within the home
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 |
|---|---|---|
| Daily monitoring of alcohol & drug use, & therapy skillsAlso: relapse preventionComparison(s): patients completing group CBT for substance abuse will be randomly assigned to two conditions. In one condition, patients will have unlimited access to the therapeutic telephone system for 4 months. The other condition is standard care (i.e., no formal relapse prevention). | Behavioural | 1 Therapeutic Phone System |
| control groupstandard care (no added treatment) | Behavioural | 2 Standard care |
Primary outcome
Amount of alcohol and use
Time frame: 4 months and one year
drinks per day, drinks per drinking day, percent days abstinent, heavy drinking days
1 secondary outcome
Utilization of the telephone system components during the study
Time frame: 4 months and one year
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 21 Jun 2012.
- Investigator's home pageLink provided by the sponsor.
Related trials for Alcoholism
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingPhase 1
Environment and Alcohol: A Pilot Study
Alcohol Use Disorder
RecruitingObservational study
SMART-r: Substance Monitoring and Active Relapse Tracking Repository
Alcoholism, Substance-Related Disorders
Not yet recruiting
A MRT to Optimize a JITAI for Alcohol Craving and Suicide Ideation
Alcohol Use Disorder (AUD), Suicide Ideation
RecruitingPhase 2
Study on Thiamine Supplementation to REduce braiN Injury Associated With Chronic Alcohol Use in Outpatients With Alcohol Use Disorder
Alcohol Use Disorder
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.
John E. Helzer, MD principal investigator
University of Vermont
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Daily monitoring of alcohol & drug use, & therapy skills in people with Alcoholism, run by University of Vermont 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 4 inclusion and 7 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 21 Jun 2012. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Amount of alcohol and use (time frame: 4 months and one year). 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 21 Jun 2012.