title: Open-label pilot study of testosterone patch therapy in men with opioid-induced androgen deficiency.
abstract: We conducted a 24-week open-label pilot study of testosterone (T) patch therapy in 23 men with opioid-induced androgen deficiency (OPIAD). The T dosage was 5 mg/day for the first 12 weeks and 7.5 mg/day for the second 12 weeks. Seven subjects discontinued prematurely: 4 for noncompliance, 2 for skin irritation and 1 for hepatitis C treatment. In the "completers" population (n = 16), mean (SD) free T levels (normal range 52 to 280 pg/mL) were 28.5 (18.6) pg/mL at baseline, 72.8 (29.6) pg/mL on 5 mg/day (P < .001 vs. baseline), and 120.2 (69.5) pg/mL on 7.5 mg/day (P < .001 vs. baseline and P < .01 vs. 5 mg/day). Total T, dihydrotestosterone, and estradiol showed parallel changes. Sex hormone-binding globulin levels were elevated at baseline and decreased modestly with treatment (P < .05 vs. baseline at 5 mg/day; P < .01 vs. baseline at 7.5 mg/day). Luteinizing hormone levels were in the low-normal range at baseline and suppressed markedly with treatment (P < .001 vs. baseline at both doses). Androgen deficiency symptoms (ADSQ), sexual function (Watts SFQ), mood (PGWB), depression (BDI-II), and hematocrit levels showed improvement during treatment, generally more so at the 7.5 mg/day dosage (P < .001 vs. baseline for most parameters). Pain scores (BPI-SF) decreased slightly on 7.5 mg/day (interference score: P < .05 vs. baseline and 5 mg/day); the use of opioids did not change appreciably. The testosterone patches were generally well tolerated.
  
  
  CONCLUSIONS
  Long-acting opioid preparations suppress the hypothalamic-pituitary-gonadal axis in men and produce a symptomatic state of opioid-induced androgen deficiency (OPIAD). Testosterone patch therapy at a dose of 7.5 mg/day normalizes hormone levels and appears to improve a number of quality of life parameters (eg, sexual function, well-being, mood) in men with OPIAD.
authors.affiliation: Department of Family Practice, University of California Davis Medical School, Redding, California, USA.
authors.forename: Harry W
authors.initials: HW
authors.lastname: Daniell
authors.forename: Robin
authors.initials: R
authors.lastname: Lentz
authors.forename: Norman A
authors.initials: NA
authors.lastname: Mazer
mesh_terms: D000279:Administration, Cutaneous; D000328:Adult; D000701:Analgesics, Opioid / Q000008:administration & dosage / Q000009:adverse effects; D000728:Androgens / Q000008:administration & dosage* / Q000172:deficiency*; D004305:Dose-Response Relationship, Drug; D004958:Estradiol / Q000097:blood; D006801:Humans; D008297:Male; D008875:Middle Aged; D010146:Pain / Q000097:blood / Q000188:drug therapy / Q000523:psychology; D010865:Pilot Projects; D012738:Sex Hormone-Binding Globulin / Q000378:metabolism; D013577:Syndrome; D013739:Testosterone / Q000008:administration & dosage*; D045165:Testosterone Congeners / Q000097:blood; D016896:Treatment Outcome
chemical_list: D000701:Analgesics, Opioid; D000728:Androgens; D012738:Sex Hormone-Binding Globulin; D045165:Testosterone Congeners; D013739:Testosterone; D004958:Estradiol