Drug AddictionPhase 2/3HOPENCT00496990
Treating the Partners of Drug Using Pregnant Women: Stage II
A Phase 2/3 study testing Enhanced care in people with Drug Addiction, run by Johns Hopkins University at 1 site in United States.
Trial summary
This is a two group randomized design that will compare a novel therapy package (i.e., Research supported treatment intervention, Contingency-based voucher incentives for the male partner's drug abstinence, Specialized MI couples counseling) to standard care for helping drug using partners of drug dependent pregnant… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Drug Addiction
- What is being tested?
- Enhanced care
- 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
- Oct 2005to Jun 2010
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- are 18 years of age or older on admission;
- Pregnant as determined by sonogram results
- have a current sexual partner who they have seen recently at least 3 times a week
- male partner has regular alcohol or illicit drug use (at least 4 of 7 days typical use) and is not incarcerated.
Who cannot join
- woman or partner report current suicidal ideation
- woman or partner meet diagnostic criteria for a current DSM-IV Axis I thought disorder (i.e. schizophrenia)
- woman or partner demonstrate significant cognitive impairment that precludes them from completing the initial assessment battery
- woman has evidence of physical violence or abuse
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Addiction and Pregnancy Johns Hopkins Bayview Medical Center
Baltimore, Maryland, 21224
About this study
This is a two group randomized design that will compare a novel therapy package (i.e., Research supported treatment intervention, Contingency-based voucher incentives for the male partner's drug abstinence, Specialized MI couples counseling) to standard care for helping drug using partners of drug dependent pregnant women obtain and maintain drug abstinence. Participants will be followed for 22 weeks and have scheduled twice weekly urine sample collection and all participants will have follow-up interviews post-study entry.
- Conditions
- Drug Addiction
- Being tested
- Enhanced care, control
- Keywords
- male, female, couple, cocaine, opiate, methadone, detoxification, pregnancy
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced careBehavioural
this group received counseling, contingency management and methadone or detoxification
controlBehavioural
this group receives the opportunity to participate in a support group
| Study group | Role | What they receive |
|---|---|---|
| control | Active comparator | Participants in this group receive the opportunity to attend a support group Receives: Behavioral: control |
| Enhanced care | Experimental | Participants in this arm receive the opportunity to have detoxification or methadone treatment as well as receive vouchers contingent upon drug free urine samples and individualized counseling Receives: Behavioral: Enhanced care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Partner Objective Substance Use
Measured: treatment entry until 28 weeks later
Secondary outcomes (1)
Woman's drug use will be measured with urine toxicology
Measured: treatment entry until 28 weeks later
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 startOct 2005
- Primary completionJun 2009
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- 158 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 Jones, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00496990
- Sponsor's protocol ID
- R01DA013496
- Other IDs
- R01DA013496, DPMCDA
- Acronym
- HOPE
- Status last verified
- Mar 2013
- First submitted
- 5 Jul 2007
- Last updated
- 5 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Lund IO, Kirtadze I, Otiashvili D, O'Grady KE, Jones HE. Female partners of opioid-injecting men in the Republic of Georgia: an initial characterization. Subst Abuse Treat Prev Policy. 2012 Nov 16;7:46. doi: 10.1186/1747-597X-7-46.
PubMed 23157895Kirtadze I, Otiashvili D, O'Grady KE, Jones HE. Behavioral treatment + naltrexone reduces drug use and legal problems in the Republic of Georgia. Am J Drug Alcohol Abuse. 2012 Mar;38(2):171-5. doi: 10.3109/00952990.2011.643996. Epub 2012 Jan 5.
PubMed 22221277Jones HE, Tuten M, O'Grady KE. Treating the partners of opioid-dependent pregnant patients: feasibility and efficacy. Am J Drug Alcohol Abuse. 2011 May;37(3):170-8. doi: 10.3109/00952990.2011.563336. Epub 2011 Mar 17.
PubMed 21410418
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
- Treating the Partners of Drug Using Pregnant Women: Stage II
- ClinicalTrials.gov ID
- NCT00496990
- Acronym / sponsor ID
- HOPE / R01DA013496
- Conditions
- Drug Addiction
- Keywords
- male, female, couple, cocaine, opiate, methadone, detoxification, pregnancy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 158 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Oct 2005
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2010 (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.
This is a two group randomized design that will compare a novel therapy package (i.e., Research supported treatment intervention, Contingency-based voucher incentives for the male partner's drug abstinence, Specialized MI couples counseling) to standard care for helping drug using partners of drug dependent pregnant women obtain and maintain drug abstinence. Participants will be followed for 22 weeks and have scheduled twice weekly urine sample collection and all participants will have follow-up interviews post-study entry.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | Active comparator | Behavioral: controlParticipants in this group receive the opportunity to attend a support group |
| Enhanced care | Experimental | Behavioral: Enhanced careParticipants in this arm receive the opportunity to have detoxification or methadone treatment as well as receive vouchers contingent upon drug free urine samples and individualized counseling |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- are 18 years of age or older on admission;
- Pregnant as determined by sonogram results
- have a current sexual partner who they have seen recently at least 3 times a week
- male partner has regular alcohol or illicit drug use (at least 4 of 7 days typical use) and is not incarcerated.
Key exclusion criteria (4 listed)
- woman or partner report current suicidal ideation
- woman or partner meet diagnostic criteria for a current DSM-IV Axis I thought disorder (i.e. schizophrenia)
- woman or partner demonstrate significant cognitive impairment that precludes them from completing the initial assessment battery
- woman has evidence of physical violence or abuse
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 |
|---|---|---|
| Enhanced carethis group received counseling, contingency management and methadone or detoxification | Behavioural | Enhanced care |
| controlthis group receives the opportunity to participate in a support group | Behavioural | control |
Primary outcome
Partner Objective Substance Use
Time frame: treatment entry until 28 weeks later
1 secondary outcome
Woman's drug use will be measured with urine toxicology
Time frame: treatment entry until 28 weeks later
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.
- Derived from this study: PubMed 23157895Lund IO, Kirtadze I, Otiashvili D, O'Grady KE, Jones HE. Female partners of opioid-injecting men in the Republic of Georgia: an initial characterization. Subst Abuse Treat Prev Policy. 2012 Nov 16;7:46. doi: 10.1186/1747-597X-7-46.
- Derived from this study: PubMed 22221277Kirtadze I, Otiashvili D, O'Grady KE, Jones HE. Behavioral treatment + naltrexone reduces drug use and legal problems in the Republic of Georgia. Am J Drug Alcohol Abuse. 2012 Mar;38(2):171-5. doi: 10.3109/00952990.2011.643996. Epub 2012 Jan 5.
- Derived from this study: PubMed 21410418Jones HE, Tuten M, O'Grady KE. Treating the partners of opioid-dependent pregnant patients: feasibility and efficacy. Am J Drug Alcohol Abuse. 2011 May;37(3):170-8. doi: 10.3109/00952990.2011.563336. Epub 2011 Mar 17.
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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 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 Enhanced care 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 4 inclusion and 4 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?
Partner Objective Substance Use (time frame: treatment entry until 28 weeks later). 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 NCT00496990, which also lists 3 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 5 Mar 2013.