Drug AddictionPhase 2/3HOMENCT00497302
Recovery Housing For Drug Dependent Pregnant Women
A Phase 2/3 study testing RBT in people with Drug Addiction, run by Johns Hopkins University at 1 site in United States.
Trial summary
For the past several years our research program has developed and tested an intensive outpatient intervention that is based in social learning theory and employs abstinence contingent access to recovery housing as a routine aspect of an intensive day treatment counseling program. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Drug Addiction
- What is being tested?
- RBT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2004to Aug 2009
- Phase
- Phase 2/3
- 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 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- CAP enrolled
- Age 18 or older
- Evidence of use of opiate and/or cocaine use in the past 30 days
- Assigned to pharmacotherapy free modality
- CAP admission at an estimated gestational age (EGA) <34 weeks
Who cannot join
- Endorses current suicidal ideation
- Any medical disorders requiring extended or future hospitalization
- Meet diagnostic criteria for current DSM-IV alcohol dependence
- Meet diagnostic criteria for a current DSM-IV Axis I thought disorder (i.e. schizophrenia)
- Demonstrate significant cognitive impairment that precludes them from completing the initial assessment battery
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Addiction and Pregnancy Jhons Hopkins Bayview Medical Center
Baltimore, Maryland, 21224
About this study
For the past several years our research program has developed and tested an intensive outpatient intervention that is based in social learning theory and employs abstinence contingent access to recovery housing as a routine aspect of an intensive day treatment counseling program. The present project proposes to extend this treatment intervention to the special population of pregnant drug using women enrolled at the Center for Addiction and Pregnancy (CAP). We will compare an enhanced treatment that includes abstinence contingent recovery house living plus intensive individual therapy, to standard care at the CAP program. Specific aims of the project are derived from testing a two-group design are described below:
- To determine whether financially supported abstinence-contingent recovery house placement plus individual counseling in pregnant drug-dependent women improves prenatal outpatient treatment retention.
- To determine whether financially supported abstinence-contingent recovery house placement plus individual counseling in pregnant drug-dependent women reduces prenatal drug use.
- To determine whether financially supported abstinence-contingent recovery house placement plus individual counseling results in better maternal and infant clinical birth outcomes (e.g., birth weight, estimated gestational age (EGA) at delivery, medical complications).
- Conditions
- Drug Addiction
- Being tested
- RBT, usual care
- Keywords
- cocaine, opiate, pregnancy, post-partum, neonatal abstinence syndrome, contingency management, Reinforcement Based Treatment, women
- Medical subject headings
- Substance-Related Disorders, Neonatal Abstinence Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RBTBehavioural
Contingency management and behavioral counseling including motivational interviewing
usual careBehavioural
receives usual comprehensive care at Center for Addiction and Pregnancy
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | receives housing based on drug abstinence Receives: Behavioral: RBT |
| 2 | Active comparator | Usual care treatment at the Center for Addiction and Pregnancy Receives: Behavioral: usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment retention, drug free urine samples at follow-up and delivery
Measured: treatment entry until 12 months post treatment entry
Secondary outcomes (1)
prenatal care compliance, neonatal and birth outcomes
Measured: treatment entry until 12 months post treatment entry
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2007 (estimated)
- Study startNov 2004
- Primary completionJun 2008
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug AddictionStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Hendree E. Jones, Johns Hopkins University
- Investigators
- Hendree E Jones, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00497302
- Sponsor's protocol ID
- R01DA014979
- Other IDs
- R01DA014979, DPMCDA
- Acronym
- HOME
- Status last verified
- Mar 2013
- First submitted
- 5 Jul 2007
- Last updated
- 5 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recovery Housing For Drug Dependent Pregnant Women
- ClinicalTrials.gov ID
- NCT00497302
- Acronym / sponsor ID
- HOME / R01DA014979
- Conditions
- Drug Addiction
- Keywords
- cocaine, opiate, pregnancy, post-partum, neonatal abstinence syndrome, contingency management, Reinforcement Based Treatment, women
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Nov 2004
- Primary completion
- Jun 2008 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 6 Jul 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.
For the past several years our research program has developed and tested an intensive outpatient intervention that is based in social learning theory and employs abstinence contingent access to recovery housing as a routine aspect of an intensive day treatment counseling program. The present project proposes to extend this treatment intervention to the special population of pregnant drug using women enrolled at the Center for Addiction and Pregnancy (CAP). We will compare an enhanced treatment that includes abstinence contingent recovery house living plus intensive individual therapy, to standard care at the CAP program. Specific aims of the project are derived from testing a two-group design are described below:
- To determine whether financially supported abstinence-contingent recovery house placement plus individual counseling in pregnant drug-dependent women improves prenatal outpatient treatment retention.
- To determine whether financially supported abstinence-contingent recovery house placement plus individual counseling in pregnant drug-dependent women reduces prenatal drug use.
- To determine whether financially supported abstinence-contingent recovery house placement plus individual counseling results in better maternal and infant clinical birth outcomes (e.g., birth weight, estimated gestational age (EGA) at delivery, medical complications).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: RBTreceives housing based on drug abstinence |
| 2 | Active comparator | Behavioral: usual careUsual care treatment at the Center for Addiction and Pregnancy |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- CAP enrolled
- Age 18 or older
- Evidence of use of opiate and/or cocaine use in the past 30 days
- Assigned to pharmacotherapy free modality
- CAP admission at an estimated gestational age (EGA) <34 weeks
Key exclusion criteria (5 listed)
- Endorses current suicidal ideation
- Any medical disorders requiring extended or future hospitalization
- Meet diagnostic criteria for current DSM-IV alcohol dependence
- Meet diagnostic criteria for a current DSM-IV Axis I thought disorder (i.e. schizophrenia)
- Demonstrate significant cognitive impairment that precludes them from completing the initial assessment battery
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 |
|---|---|---|
| RBTContingency management and behavioral counseling including motivational interviewing | Behavioural | 1 |
| usual carereceives usual comprehensive care at Center for Addiction and Pregnancy | Behavioural | 2 |
Primary outcome
Treatment retention, drug free urine samples at follow-up and delivery
Time frame: treatment entry until 12 months post treatment entry
1 secondary outcome
prenatal care compliance, neonatal and birth outcomes
Time frame: treatment entry until 12 months post treatment entry
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 5 Mar 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.
Hendree E Jones, PhD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing RBT in people with Drug Addiction, run by Johns Hopkins University 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 5 inclusion and 5 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 5 Mar 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Treatment retention, drug free urine samples at follow-up and delivery (time frame: treatment entry until 12 months post treatment entry). 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 5 Mar 2013.