Abstract
Objective(s)
To characterize for the first time the side effect profile, safety, and tolerability
of hormonal contraception among women receiving opioid-agonist therapy.
Study Design
We conducted a secondary analysis of data collected from participants in a three-arm
randomized controlled trial (N = 138) aimed at increasing effective contraceptive use among women receiving opioid-agonist
therapy. Participants in the 2 intervention conditions (n = 90) had free access to hormonal contraception at each of the 14 visits scheduled
during the 6-month intervention. Contraceptive use and side effects were recorded
at each visit; participants could change methods or discontinue use at any time. Verbatim
side effects were classified using Medical Dictionary for Regulatory Activities (MedDRA)
terminology.
Results
Of 67 participants reporting hormonal contraceptive use, 29 (43%) initiated implants,
14 (21%) intrauterine devices, 13 (19%) combined pills, 11 (16%) progestin-only pills,
10 (15%) injectables, 1 (2%) ring, and 1 (2%) patch; the average (±standard deviation)
duration of use was 129 ± 55, 129 ± 60, 108 ± 62, 102 ± 61, 111 ± 31, 145, and 18
days, respectively. A total of 321 side effects were reported by 55 (82%) participants.
Fifty (75%) participants reported menstrual cycle changes/uterine bleeding, followed
by headaches (16, 24%), weight gain (15, 22%), and abdominal pain or nausea/vomiting
(11, 16%). No serious side effects were reported. Twelve participants (18%) changed
methods and 13 (19%) discontinued all hormonal contraceptive use.
Conclusion(s)
The hormonal contraceptive side effects reported by this small group of women receiving
opioid-agonist therapy appear consistent with those reported by the general population,
was generally well-tolerated, and did not raise safety concerns.
Implications
These results provide important preliminary evidence that hormonal contraceptive use
produces a familiar side effect profile and is well-tolerated by women receiving opioid-agonist
therapy, although studies with larger samples followed over longer periods of time
with appropriate comparison conditions are needed to fully assess tolerability and
safety.
Keywords
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Article info
Publication history
Published online: March 10, 2022
Accepted:
February 28,
2022
Received in revised form:
February 26,
2022
Received:
November 20,
2021
Footnotes
✰Declaration of Competing Interest: None.
✰Funding: This work was supported by the National Institute on Drug Abuse [Grant numbers R01DA036670, R01DA047867, and T32DA07242], the National Institute of General Medical Sciences [P20GM103644], and Health Resources and Services Administration [UD9RH33633].
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