Contraceptive UsagePhase 1NCT01425060
Improving Effective Contraceptive Use Among Opioid-maintained Women
A Phase 1 study testing Contraceptive management program in people with Contraceptive Usage and Opioid Dependence, run by University of Vermont at 1 site in United States.
Trial summary
Nearly 9 of every 10 pregnant opioid-dependent women report that the current pregnancy was unintended and the majority of non-pregnant opioid-maintained women do not use contraception or use less effective methods like condoms. Read more about this study
- Who is it for?
- Ages 18 to 44 years, women only
- Conditions the study is for
- Contraceptive Usage, Opioid Dependence
- What is being tested?
- Contraceptive management program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2011to Jun 2014
- 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 18 to 44 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 18-44 years of age
- pre-menopausal and have no history of a tubal ligation or hysterectomy
- have had heterosexual vaginal sex in the past 12 months
- have no plans to become pregnant in the next 6 months
- be medically eligible to use prescription contraceptives
- report no prescription contraceptive method use (i.e., no use of pills, patch, ring in the past 7 days or depot injections, implants, or IUD in the past 3 months) OR report primary use of a non-prescription method (i.e., condoms, sponge, diaphragm, withdrawal, or rhythm method)
- have been in opioid maintenance treatment for at least the past 30 days
- be English-speaking.
Who cannot join
- failure to meet the aforementioned inclusion criteria
- refusal to participate
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Vermont Substance Abuse Treatment Center
Burlington, Vermont, 05401
About this study
Nearly 9 of every 10 pregnant opioid-dependent women report that the current pregnancy was unintended and the majority of non-pregnant opioid-maintained women do not use contraception or use less effective methods like condoms. This proposal aims to develop and test a novel contraceptive management program to increase use of more effective contraceptives among opioid-maintained women and to examine the impact of more effective contraceptive use on condom use. The proposed research may reduce unintended pregnancy among opioid-dependent women without increasing their risk of sexually transmitted infections and the knowledge gained will also have implications for addressing high rates of unintended pregnancy in the general population.
Read the detailed description
The rate of unintended pregnancy among opioid-dependent women is extremely high: nearly 9 of every 10 pregnant opioid-dependent women report that the current pregnancy was unintended, a rate 2-3 times that of the general population. Despite these dire statistics, there is a dearth of scientific knowledge about contraceptive use in this population and about how to promote use of more effective contraceptives (e.g., birth control pills, IUDs, implants).
The aim of this Stage I Behavioral and Integrative Treatment Development Program application is to develop and pilot test a novel contraceptive management program to increase use of more effective contraceptives among OM women. OM women (N=100) at risk for unintended pregnancy will be randomly assigned to a 6-month contraceptive management program or to usual care. The contraceptive management program will consist of two components: (1) the World Health Organization's contraception protocol and (2) reinforced follow-up visits. At their first visit, participants assigned to the contraceptive management program will complete the WHO's contraception protocol, which consists of assistance choosing a contraceptive method, structured educational counseling about their chosen method, a free supply of this method, and the option of initiating this method immediately. Subsequently, contraceptive management program participants will earn voucher-based incentives to reinforce attendance at follow-up visits where they will receive support to manage side effects and problem-solve compliance problems, refills of their chosen method, and assistance switching methods when indicated. At each visit, contraceptive management program participants will also be counseled about the risks of sexually transmitted infections (STIs), including HIV/AIDS, the need for dual protection (i.e., protection from both pregnancy and STIs), and provided with a supply of condoms. Participants assigned to the usual care condition will be given general information about contraceptive options and contact information for clinics and providers that provide contraceptive services. Contraceptive use by all participants will be evaluated at assessments scheduled 1, 3, and 6 months after trial intake. The impact of prescription contraceptive use on condom use will also be assessed. It is hypothesized that the contraceptive management program will increase effective contraceptive use without decreasing condom use.
The proposed project will be the seminal study of an intervention to increase more effective contraceptive use in OM women and the first step towards our overarching goal of developing an efficacious, empirically based contraceptive management program that can be disseminated to drug treatment facilities throughout the country. The proposed research also holds significant potential for impacting public health in general, as development of efficacious programs will help reduce the vast economic and societal costs associated with unintended pregnancy among drug-dependent and non-drug-dependent women alike.
- Conditions
- Contraceptive Usage, Opioid Dependence
- Being tested
- Contraceptive management program, Usual care
- Keywords
- Contraception, Unintended pregnancy, HIV, HIV Risk, Sexually Transmitted Infections, Women, Pregnancy, Neonatal Health, Drug Use, Drug Treatment, Opioids
- Medical subject headings
- Contraception Behavior, Opioid-Related Disorders, Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contraceptive management programBehavioural
The contraceptive management program will consist of two components: (1) the World Health Organization's contraception protocol and (2) reinforced follow-up visits.
Usual careOther
The usual care condition will be given general information about contraceptive options and contact information for clinics and providers that provide contraceptive services.
| Study group | Role | What they receive |
|---|---|---|
| Contraceptive management program | Experimental | Not described Receives: Behavioral: Contraceptive management program |
| Usual care | Active comparator | The usual care condition will be given general information about contraceptive options and contact information for clinics and providers that provide contraceptive services. Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Point prevalence use of a prescription contraceptive
Measured: 6 months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2011 (estimated)
- Study startOct 2011
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Contraceptive UsageStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Vermont
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sarah Heil, University of Vermont
- Investigators
- Sarah H. Heil, Ph.D., Principal investigator, University of Vermont
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01425060
- Sponsor's protocol ID
- R34DA030534
- Status last verified
- Mar 2015
- First submitted
- 25 Aug 2011
- Last updated
- 17 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Heil SH, Higgins ST. The scientific and ethical rationale for using incentives to promote contraceptive use among drug-abusing women. Addiction. 2012 Jun;107(6):1044-6. doi: 10.1111/j.1360-0443.2012.03798.x. No abstract available.
PubMed 22563830Heil SH, Gaalema DE, Johnston AM, Sigmon SC, Badger GJ, Higgins ST. Infant pupillary response to methadone administration during treatment for neonatal abstinence syndrome: a feasibility study. Drug Alcohol Depend. 2012 Nov 1;126(1-2):268-71. doi: 10.1016/j.drugalcdep.2012.05.006. Epub 2012 Jun 8.
PubMed 22682657Hand DJ, Heil SH, Sigmon SC, Higgins ST. Improving medicaid health incentives programs: lessons from substance abuse treatment research. Prev Med. 2014 Jun;63:87-9. doi: 10.1016/j.ypmed.2014.03.001. Epub 2014 Mar 12.
PubMed 24613792Herrmann ES, Hand DJ, Johnson MW, Badger GJ, Heil SH. Examining delay discounting of condom-protected sex among opioid-dependent women and non-drug-using control women. Drug Alcohol Depend. 2014 Nov 1;144:53-60. doi: 10.1016/j.drugalcdep.2014.07.026. Epub 2014 Jul 30.
PubMed 25190049Meyer MC, Johnston AM, Crocker AM, Heil SH. Methadone and buprenorphine for opioid dependence during pregnancy: a retrospective cohort study. J Addict Med. 2015 Mar-Apr;9(2):81-6. doi: 10.1097/ADM.0000000000000092.
PubMed 25622120
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Effective Contraceptive Use Among Opioid-maintained Women
- ClinicalTrials.gov ID
- NCT01425060
- Acronym / sponsor ID
- R34DA030534
- Conditions
- Contraceptive Usage, Opioid Dependence
- Keywords
- Contraception, Unintended pregnancy, HIV, HIV Risk, Sexually Transmitted Infections, Women, Pregnancy, Neonatal Health
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of VermontUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 29 Aug 2011 (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.
Nearly 9 of every 10 pregnant opioid-dependent women report that the current pregnancy was unintended and the majority of non-pregnant opioid-maintained women do not use contraception or use less effective methods like condoms. This proposal aims to develop and test a novel contraceptive management program to increase use of more effective contraceptives among opioid-maintained women and to examine the impact of more effective contraceptive use on condom use. The proposed research may reduce unintended pregnancy among opioid-dependent women without increasing their risk of sexually transmitted infections and the knowledge gained will also have implications for addressing high rates of unintended pregnancy in the general population.
Detailed description
The rate of unintended pregnancy among opioid-dependent women is extremely high: nearly 9 of every 10 pregnant opioid-dependent women report that the current pregnancy was unintended, a rate 2-3 times that of the general population. Despite these dire statistics, there is a dearth of scientific knowledge about contraceptive use in this population and about how to promote use of more effective contraceptives (e.g., birth control pills, IUDs, implants).
The aim of this Stage I Behavioral and Integrative Treatment Development Program application is to develop and pilot test a novel contraceptive management program to increase use of more effective contraceptives among OM women. OM women (N=100) at risk for unintended pregnancy will be randomly assigned to a 6-month contraceptive management program or to usual care. The contraceptive management program will consist of two components: (1) the World Health Organization's contraception protocol and (2) reinforced follow-up visits. At their first visit, participants assigned to the contraceptive management program will complete the WHO's contraception protocol, which consists of assistance choosing a contraceptive method, structured educational counseling about their chosen method, a free supply of this method, and the option of initiating this method immediately. Subsequently, contraceptive management program participants will earn voucher-based incentives to reinforce attendance at follow-up visits where they will receive support to manage side effects and problem-solve compliance problems, refills of their chosen method, and assistance switching methods when indicated. At each visit, contraceptive management program participants will also be counseled about the risks of sexually transmitted infections (STIs), including HIV/AIDS, the need for dual protection (i.e., protection from both pregnancy and STIs), and provided with a supply of condoms. Participants assigned to the usual care condition will be given general information about contraceptive options and contact information for clinics and providers that provide contraceptive services. Contraceptive use by all participants will be evaluated at assessments scheduled 1, 3, and 6 months after trial intake. The impact of prescription contraceptive use on condom use will also be assessed. It is hypothesized that the contraceptive management program will increase effective contraceptive use without decreasing condom use.
The proposed project will be the seminal study of an intervention to increase more effective contraceptive use in OM women and the first step towards our overarching goal of developing an efficacious, empirically based contraceptive management program that can be disseminated to drug treatment facilities throughout the country. The proposed research also holds significant potential for impacting public health in general, as development of efficacious programs will help reduce the vast economic and societal costs associated with unintended pregnancy among drug-dependent and non-drug-dependent women alike.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Contraceptive management program | Experimental | Behavioral: Contraceptive management program |
| Usual care | Active comparator | Other: Usual careThe usual care condition will be given general information about contraceptive options and contact information for clinics and providers that provide contraceptive services. |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 18-44 years of age
- pre-menopausal and have no history of a tubal ligation or hysterectomy
- have had heterosexual vaginal sex in the past 12 months
- have no plans to become pregnant in the next 6 months
- be medically eligible to use prescription contraceptives
Key exclusion criteria (2 listed)
- failure to meet the aforementioned inclusion criteria
- refusal to participate
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 |
|---|---|---|
| Contraceptive management programThe contraceptive management program will consist of two components: (1) the World Health Organization's contraception protocol and (2) reinforced follow-up visits. | Behavioural | Contraceptive management program |
| Usual careThe usual care condition will be given general information about contraceptive options and contact information for clinics and providers that provide contraceptive services. | Other | Usual care |
Primary outcome
Point prevalence use of a prescription contraceptive
Time frame: 6 months after randomization
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 17 Mar 2015.
- Background: PubMed 22563830Heil SH, Higgins ST. The scientific and ethical rationale for using incentives to promote contraceptive use among drug-abusing women. Addiction. 2012 Jun;107(6):1044-6. doi: 10.1111/j.1360-0443.2012.03798.x. No abstract available.
- Background: PubMed 22682657Heil SH, Gaalema DE, Johnston AM, Sigmon SC, Badger GJ, Higgins ST. Infant pupillary response to methadone administration during treatment for neonatal abstinence syndrome: a feasibility study. Drug Alcohol Depend. 2012 Nov 1;126(1-2):268-71. doi: 10.1016/j.drugalcdep.2012.05.006. Epub 2012 Jun 8.
- Background: PubMed 24613792Hand DJ, Heil SH, Sigmon SC, Higgins ST. Improving medicaid health incentives programs: lessons from substance abuse treatment research. Prev Med. 2014 Jun;63:87-9. doi: 10.1016/j.ypmed.2014.03.001. Epub 2014 Mar 12.
- Background: PubMed 25190049Herrmann ES, Hand DJ, Johnson MW, Badger GJ, Heil SH. Examining delay discounting of condom-protected sex among opioid-dependent women and non-drug-using control women. Drug Alcohol Depend. 2014 Nov 1;144:53-60. doi: 10.1016/j.drugalcdep.2014.07.026. Epub 2014 Jul 30.
- Background: PubMed 25622120Meyer MC, Johnston AM, Crocker AM, Heil SH. Methadone and buprenorphine for opioid dependence during pregnancy: a retrospective cohort study. J Addict Med. 2015 Mar-Apr;9(2):81-6. doi: 10.1097/ADM.0000000000000092.
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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.
Sarah H. Heil, Ph.D. 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 1 study testing Contraceptive management program in people with Contraceptive Usage and Opioid Dependence, 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 8 inclusion and 2 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 17 Mar 2015. 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?
Point prevalence use of a prescription contraceptive (time frame: 6 months after randomization). 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 NCT01425060, which also lists 5 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 17 Mar 2015.