Clinical Trial: Lupron Sex Offender Therapy
Study Status: Terminated
Recruit Status: Unknown status
Study Type: Interventional
Official Title: Leuprolide Acetate Suppresses Pedophilic Urges and Arousability
Brief Summary: This study compared cognitive-behavioral psychotherapy with leuprolide acetate (LA) to cognitive-behavioral psychotherapy with saline injections for 12 months. Five white male pedophiles (M age, 50 years; range, 36-58) volunteered for a two-year study. LA was administered by Depo injection (7 mg initially, then 22.5 mg every 3 mos) for 12 months, followed by saline placebo. Effects of LA on testosterone levels, sexual interest preference by visual reaction time (Abel Assessment), penile tumescence (Monarch PPG), as well strong urges and masturbatory frequency to children (polygraph), were measured every three months. Subjects were treated with weekly cognitive-behavioral psychotherapy. On LA, testosterone decreased to castrate levels. Because of the suppression of testosterone, physiologic arousal response as measured by penile plethysmography (penile tumescence) was significantly suppressed compared with baseline. However, sufficient response remained to detect pedophilic interest. This pedophilic interest was also detected by visual reaction times. All subjects self-reported a decrease in strong pedophilic urges and masturbation. When asked about having pedophilic urges and masturbating to thoughts of children, polygraph responses indicated subjects were not deceptive when they reported decreases. On placebo, testosterone and physiologic arousal eventually rose to baseline levels. At baseline and on placebo, subjects were consistently deceptive regarding increased pedophilic urges and masturbatory frequency as noted by polygraph. Interest preference, as measured by Abel Assessment and Monarch PPG, was generally unchanged throughout the study. Cognitive-behavioral psychotherapy augmented with LA significantly reduced pedophilic fantasies, urges, and masturbation, but did not change pedophilic interest during one year of therapy. Deceptive responses by polygraph suggested that self-report was unreliable. Follow-up utilizing objective measures is essential for monito
Detailed Summary:
Hormone therapy is aimed at modification of the basic sex drive, whereas cognitive-behavioral psychotherapy targets cognitive processes that precede all events leading to pedophilic behavior. Obsession/compulsion and sex drive might affect the decision process. Because of a suggested relationship between obsessive compulsive disorder and paraphilias, SSRIs have been utilized. Most reports have been documented from individual case studies or uncontrolled, retrospective studies (Kafka, 2000).
Reports of the efficacy of drug therapy for suppression of sexual drive and modification of behavior continue to emerge. The anti-androgens, MPA and CPA, are the most widely used drugs. They provide variable testosterone suppression, dependent on dose. LHRH inhibitors and GNRH agonists also provide profound testosterone suppression. More recently, triptorelin, an agent similar to LA, (Rosler & Wilztum, 1998) and selective serotonin reuptake inhibitors (SSRIs) have also been investigated (Raymond, Grant, Kim,.& Colemen, 2002; Stein, Hollander, Anthony, Schneier, Fallon, Liebowitz, Klein, 1992).
Despite recent advances in the use of testosterone-suppressing drugs for the treatment of pedophilia, limited information is available in the form of well designed, controlled objective studies. The lack of standardized, objective outcome measures has hampered objective assessment of efficacy of interventions for pedophilia (Briken, Hill, & Berner, 2003; Hanson et al., 2002; Marshall & Barbaree, 1990). A multi-disciplinary team of experts is needed to assess concurrent, objective physiologic measures of response. Though some results of treatment are promising, a reliable, well-tolerated approach that can be objectively monitored for efficacy is lacking.
The specific aspects of behav
Sponsor: Schober, Justine, M.D.
Current Primary Outcome: suppressed arousal
Original Primary Outcome: Same as current
Current Secondary Outcome: safety
Original Secondary Outcome: Same as current
Information By: Schober, Justine, M.D.
Dates:
Date Received: September 16, 2005
Date Started: October 2001
Date Completion: August 2005
Last Updated: September 16, 2005
Last Verified: September 2005
