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Progesterone effects on cocaine use in male cocaine users maintained on methadone: a randomized, double-blind, pilot study.
Exp Clin Psychopharmacol. 2007 Oct; 15(5):453-60.EC

Abstract

Previously, the authors reported that progesterone treatment attenuated reports of cocaine-induced high in male and female cocaine users. In this pilot clinical trial, the authors tested the safety and efficacy of oral progesterone as a treatment for cocaine dependence in methadone-stabilized male cocaine users. This was a 10-week, randomized, double-blind, placebo-controlled trial. Forty-five male methadone-stabilized cocaine users were randomized to receive placebo (n=15) or progesterone (n=30) for 9 weeks. The progesterone dose was gradually increased from 100 mg to 300 mg twice daily by Week 4 and maintained through Week 10. Treatment retention for the clinical trial was 80%, without significant group differences (log rank=2.4, p=.12). Hierarchical linear modeling estimates of obtaining a cocaine positive urine result across 10 weeks showed a very slight reduction in cocaine use for the progesterone group (Z=-2.89, p<.004). The placebo group showed a slight increase in cocaine use from Week 1 to Week 10 (Z=2.72, p<.007). These slopes significantly differed from each other (Z=-3.83, p<.0001). Overall, the placebo group showed significantly lower probability of having a cocaine positive urine result at treatment's end (Weeks 9 and 10) compared with the progesterone group (0.60 vs. 0.73; U=4837, p<.04). These preliminary findings do not support the efficacy of progesterone in male cocaine users. The efficacy of progesterone in female cocaine users remains to be determined in future studies.

Authors+Show Affiliations

Department of Psychiatry, Yale University School of Medicine, Veterans Affairs Connecticut Healthcare System, Connecticut, USA. mehmet.sofuoglu@yale.eduNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, N.I.H., Extramural
Research Support, U.S. Gov't, Non-P.H.S.

Language

eng

PubMed ID

17924779

Citation

Sofuoglu, Mehmet, et al. "Progesterone Effects On Cocaine Use in Male Cocaine Users Maintained On Methadone: a Randomized, Double-blind, Pilot Study." Experimental and Clinical Psychopharmacology, vol. 15, no. 5, 2007, pp. 453-60.
Sofuoglu M, Poling J, Gonzalez G, et al. Progesterone effects on cocaine use in male cocaine users maintained on methadone: a randomized, double-blind, pilot study. Exp Clin Psychopharmacol. 2007;15(5):453-60.
Sofuoglu, M., Poling, J., Gonzalez, G., Gonsai, K., Oliveto, A., & Kosten, T. R. (2007). Progesterone effects on cocaine use in male cocaine users maintained on methadone: a randomized, double-blind, pilot study. Experimental and Clinical Psychopharmacology, 15(5), 453-60.
Sofuoglu M, et al. Progesterone Effects On Cocaine Use in Male Cocaine Users Maintained On Methadone: a Randomized, Double-blind, Pilot Study. Exp Clin Psychopharmacol. 2007;15(5):453-60. PubMed PMID: 17924779.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Progesterone effects on cocaine use in male cocaine users maintained on methadone: a randomized, double-blind, pilot study. AU - Sofuoglu,Mehmet, AU - Poling,James, AU - Gonzalez,Gerardo, AU - Gonsai,Kishorchandra, AU - Oliveto,Alison, AU - Kosten,Thomas R, PY - 2007/10/11/pubmed PY - 2007/12/28/medline PY - 2007/10/11/entrez SP - 453 EP - 60 JF - Experimental and clinical psychopharmacology JO - Exp Clin Psychopharmacol VL - 15 IS - 5 N2 - Previously, the authors reported that progesterone treatment attenuated reports of cocaine-induced high in male and female cocaine users. In this pilot clinical trial, the authors tested the safety and efficacy of oral progesterone as a treatment for cocaine dependence in methadone-stabilized male cocaine users. This was a 10-week, randomized, double-blind, placebo-controlled trial. Forty-five male methadone-stabilized cocaine users were randomized to receive placebo (n=15) or progesterone (n=30) for 9 weeks. The progesterone dose was gradually increased from 100 mg to 300 mg twice daily by Week 4 and maintained through Week 10. Treatment retention for the clinical trial was 80%, without significant group differences (log rank=2.4, p=.12). Hierarchical linear modeling estimates of obtaining a cocaine positive urine result across 10 weeks showed a very slight reduction in cocaine use for the progesterone group (Z=-2.89, p<.004). The placebo group showed a slight increase in cocaine use from Week 1 to Week 10 (Z=2.72, p<.007). These slopes significantly differed from each other (Z=-3.83, p<.0001). Overall, the placebo group showed significantly lower probability of having a cocaine positive urine result at treatment's end (Weeks 9 and 10) compared with the progesterone group (0.60 vs. 0.73; U=4837, p<.04). These preliminary findings do not support the efficacy of progesterone in male cocaine users. The efficacy of progesterone in female cocaine users remains to be determined in future studies. SN - 1064-1297 UR - https://www.unboundmedicine.com/medline/citation/17924779/Progesterone_effects_on_cocaine_use_in_male_cocaine_users_maintained_on_methadone:_a_randomized_double_blind_pilot_study_ L2 - http://content.apa.org/journals/pha/15/5/453 DB - PRIME DP - Unbound Medicine ER -