End Stage Liver DiseasePhase 1/2NCT00249652
Transplant and Addiction Project (TAP) - 1
A Phase 1/2 study testing TAP and TAU in people with End Stage Liver Disease and End Stage Renal Disease, run by St. Luke's-Roosevelt Hospital Center at 3 sites in United States.
Trial summary
The purpose of this study is to test a novel distance-based (telephone) intervention to help transplant candidates with current or recent substance abuse to stay "clean and sober" both prior and following transplant surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Liver Disease, End Stage Renal Disease, Substance-Related Disorders
- What is being tested?
- TAP and TAU
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 3 sitesUnited States
- Study dates
- Sep 2003to Sep 2009
- Phase
- Phase 1/2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- End stage liver or renal disease
- Having used drugs or alcohol during the past 6 months
- Turned down for transplant due to current or recent substance use
- Access to telephone
Who cannot join
- Psychotic or other unstable serious psychiatric disorders that preclude full, active participation
- Moderate to severe hepatic encephalopathy
- Non-English speaking
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Behavioral Science Research Unit
New York, New York, 10025
Renal & Islet Transplant, Center for Liver Disease
New York, New York, 10032
Liver Transplant Program
Richmond, Virginia, 23298
About this study
Official title: Drug Treatment for Transplant Candidates
The purpose of this study is to test a novel distance-based (telephone) intervention to help transplant candidates with current or recent substance abuse to stay "clean and sober" both prior and following transplant surgery.
Read the detailed description
Participants who need a liver or renal transplant and who are ineligible due to current or recent (past 6 months) alcohol and/or other drug abuse are being recruited from the transplant programs at St. Luke's-Roosevelt Hospital Center (renal), Columbia Presbyterian Hospital (renal/liver) and Virginia Commonwealth University Medical Center (liver). Baseline and follow-up computer-assisted assessments and structured clinical interviews along with collection of biological samples (urine, hair) will occur in the transplant clinics; however, phone counseling sessions originate at St. Luke's. Participants are randomly assigned to one of two treatments: (1) usual care (no phone counseling) or (2) usual care + counseling. The telephone counseling sessions are designed to help participants become motivated to remain abstinent and improve other health behaviors such as sleep or stress management.
- Being tested
- TAP, TAU
- Keywords
- End stage liver disease, End stage renal disease, Substance-Related Disorders
- Medical subject headings
- End Stage Liver Disease, Kidney Failure, Chronic, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAPBehavioural
12-session motivational interviewing-based telephone intervention.
TAUOther
The usual care group will receive the same medical services they would otherwise receive if they were not in this study.
| Study group | Role | What they receive |
|---|---|---|
| TAP | Experimental | MI-based phone intervention. Receives: Behavioral: TAP |
| TAU | Other | Treatment As Usual Receives: Other: TAU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abstinence
Measured: 3 month time frame
Secondary outcomes (1)
Stage of Change, illness response, psychological stress
Measured: 3 month time frame
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2005 (estimated)
- Study startSep 2003
- Primary completionJun 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for End Stage Liver DiseaseStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Luke's-Roosevelt Hospital Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Deborah Haller, Principal investigator, St. Luke's Roosevelt Hosp Cntr (New York)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00249652
- Sponsor's protocol ID
- NIDA-15772-1
- Other IDs
- R01-15772-1
- Status last verified
- Apr 2015
- First submitted
- 3 Nov 2005
- Last updated
- 14 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Wagner CC, Haller DL, Olbrisch ME. Relapse prevention treatment for liver transplant patients. J Clin Psychol Med Settings. 1996 Dec;3(4):387-98. doi: 10.1007/BF01994021.
PubMed 24226847Presented at the Ninth Annual International Liver Transplantation Society Congress, Barcelona, Spain, June 2003.
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drug Treatment for Transplant Candidates
- ClinicalTrials.gov ID
- NCT00249652
- Acronym / sponsor ID
- NIDA-15772-1
- Keywords
- End stage liver disease, End stage renal disease, Substance-Related Disorders
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- St. Luke's-Roosevelt Hospital CenterUniversity, hospital or other
- Study start
- Sep 2003
- Primary completion
- Jun 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 7 Nov 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 test a novel distance-based (telephone) intervention to help transplant candidates with current or recent substance abuse to stay "clean and sober" both prior and following transplant surgery.
Detailed description
Participants who need a liver or renal transplant and who are ineligible due to current or recent (past 6 months) alcohol and/or other drug abuse are being recruited from the transplant programs at St. Luke's-Roosevelt Hospital Center (renal), Columbia Presbyterian Hospital (renal/liver) and Virginia Commonwealth University Medical Center (liver). Baseline and follow-up computer-assisted assessments and structured clinical interviews along with collection of biological samples (urine, hair) will occur in the transplant clinics; however, phone counseling sessions originate at St. Luke's. Participants are randomly assigned to one of two treatments: (1) usual care (no phone counseling) or (2) usual care + counseling. The telephone counseling sessions are designed to help participants become motivated to remain abstinent and improve other health behaviors such as sleep or stress management.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TAP | Experimental | Behavioral: TAPMI-based phone intervention. |
| TAU | Other | Other: TAUTreatment As Usual |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- End stage liver or renal disease
- Having used drugs or alcohol during the past 6 months
- Turned down for transplant due to current or recent substance use
- Access to telephone
Key exclusion criteria (3 listed)
- Psychotic or other unstable serious psychiatric disorders that preclude full, active participation
- Moderate to severe hepatic encephalopathy
- Non-English speaking
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 |
|---|---|---|
| TAP12-session motivational interviewing-based telephone intervention. | Behavioural | TAP |
| TAUThe usual care group will receive the same medical services they would otherwise receive if they were not in this study. | Other | TAU |
Primary outcome
Abstinence
Time frame: 3 month time frame
1 secondary outcome
Stage of Change, illness response, psychological stress
Time frame: 3 month time frame
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 14 Apr 2015.
- Background: PubMed 24226847Wagner CC, Haller DL, Olbrisch ME. Relapse prevention treatment for liver transplant patients. J Clin Psychol Med Settings. 1996 Dec;3(4):387-98. doi: 10.1007/BF01994021.
- BackgroundPresented at the Ninth Annual International Liver Transplantation Society Congress, Barcelona, Spain, June 2003.
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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.
Deborah Haller principal investigator
St. Luke's Roosevelt Hosp Cntr (New York)
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing TAP and TAU in people with End Stage Liver Disease and End Stage Renal Disease, run by St. Luke's-Roosevelt Hospital Center at 3 sites 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 3 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 14 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 combined 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.
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?
Abstinence (time frame: 3 month time frame). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00249652, which also lists 2 linked publications.
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 14 Apr 2015.