There is mounting interest and concern, both in the scientific community and in legislative and regulatory bodies, about the psychiatric effects of anabolic-androgenic steroids. These drugs, used illicitly by hundreds of thousands of Americans, may produce substantial psychiatric morbidity in some individuals, and may also display significant abuse potential. Thus, steroid use represents a potentially serious public health problem. To date, however, most laboratory studies of steroids have used only modest dosages of the drugs; thus, information on their psychiatric effects comes largely from naturalistic studies which have relied almost exclusively on retrospective self-reports of athletes taking uncertain doses and combinations of drugs obtained illicitly. The proposed study attempts to overcome these limitations by assessing in detail the psychiatric effects of up to 600 mg per week of testosterone cypionate, a widely abused steroid, administered in a placebo-controlled, double-blind crossover design. The study uses gradually increasing doses of the drug, together with frequent and extensive monitoring of medical and psychiatric effects, to protect the safety of the subjects. Psychiatric effects of testosterone administration and testosterone withdrawal will be monitored via four rating scales administered weekly, and by daily diaries completed by the subject himself. In addition, the investigators will obtain weekly diaries from a """"""""significant other"""""""" who knows the subject intimately, and who can observe his behavior. Physical and laboratory measures, including neuroendocrine measures, will be conducted at intervals throughout the study, both to assess potential adverse medical effects of testosterone, and to determine whether neuroendocrine changes may predict psychiatric effects. In summary, the proposed study is expected to provide psychiatric data which is more reliable and more extensive than that obtained from previous naturalistic or laboratory studies of steroid effects.

Agency
National Institute of Health (NIH)
Institute
National Institute on Drug Abuse (NIDA)
Type
Research Project (R01)
Project #
5R01DA006543-06
Application #
2118755
Study Section
Drug Abuse Clinical and Behavioral Research Review Committee (DACB)
Project Start
1990-05-01
Project End
1997-06-30
Budget Start
1995-07-01
Budget End
1996-06-30
Support Year
6
Fiscal Year
1995
Total Cost
Indirect Cost
Name
Mc Lean Hospital (Belmont, MA)
Department
Type
DUNS #
City
Belmont
State
MA
Country
United States
Zip Code
02478
Pope Jr, H G; Kouri, E M; Hudson, J I (2000) Effects of supraphysiologic doses of testosterone on mood and aggression in normal men: a randomized controlled trial. Arch Gen Psychiatry 57:133-40; discussion 155-6
Pope Jr, H G; Gruber, A J; Choi, P et al. (1997) Muscle dysmorphia. An underrecognized form of body dysmorphic disorder. Psychosomatics 38:548-57
Kouri, E M; Pope Jr, H G; Oliva, P S (1996) Changes in lipoprotein-lipid levels in normal men following administration of increasing doses of testosterone cypionate. Clin J Sport Med 6:152-7
Pope Jr, H G; Kouri, E M; Powell, K F et al. (1996) Anabolic-androgenic steroid use among 133 prisoners. Compr Psychiatry 37:322-7
Kouri, E M; Pope Jr, H G; Katz, D L et al. (1995) Fat-free mass index in users and nonusers of anabolic-androgenic steroids. Clin J Sport Med 5:223-8
Bond, A J; Choi, P Y; Pope Jr, H G (1995) Assessment of attentional bias and mood in users and non-users of anabolic-androgenic steroids. Drug Alcohol Depend 37:241-5
Pope Jr, H G; Katz, D L (1994) Psychiatric and medical effects of anabolic-androgenic steroid use. A controlled study of 160 athletes. Arch Gen Psychiatry 51:375-82
Choi, P Y; Pope Jr, H G (1994) Violence toward women and illicit androgenic-anabolic steroid use. Ann Clin Psychiatry 6:21-5
Pope Jr, H G; Katz, D L; Hudson, J I (1993) Anorexia nervosa and ""reverse anorexia"" among 108 male bodybuilders. Compr Psychiatry 34:406-9