Opioid Dependence Clinical Trial
Official title:
Improving Effective Contraceptive Use Among Opioid-maintained Women
Verified date | March 2015 |
Source | University of Vermont |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 31 |
Est. completion date | June 2014 |
Est. primary completion date | June 2014 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 44 Years |
Eligibility |
Inclusion Criteria: - 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. Exclusion Criteria: - failure to meet the aforementioned inclusion criteria - refusal to participate |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
United States | University of Vermont Substance Abuse Treatment Center | Burlington | Vermont |
Lead Sponsor | Collaborator |
---|---|
University of Vermont |
United States,
Hand 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. — View Citation
Heil 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. — View Citation
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. — View Citation
Herrmann 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. — View Citation
Meyer 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Point prevalence use of a prescription contraceptive | 6 months after randomization | No |
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