Pilot RCT of oxytocin for the treatment of opioid dependence
Research type
Research Study
Full title
A randomised double blind placebo controlled pilot trial of oxytocin efficacy in treating detoxified opioid dependent individuals
IRAS ID
148988
Contact name
Fiona Robinson
Contact email
Eudract number
2014-002708-26
Research summary
The major problem for opioid (mostly heroin) dependent individuals who are recovering from their addiction is the maintenance of a drug-free state as only around 40% of patients will maintain abstinent 1 month post detoxification. Opioid dependent individuals undergoing and following detoxification very often suffer from persistent emotional withdrawal symptoms which can trigger them to relapse back to the drug. These symptoms are associated with emotional distress and dysphoria such as anxiety (including social anxiety), irritability, stress, depression, craving, sleep disturbances and lack of pleasure and motivation which may persist for months in recovering opioid dependent individuals. In addition, recovering opioid dependent individuals often suffer from social withdrawal and social deficits which again may trigger their desire to re-use the drug of abuse and relapse. The adverse social consequences of withdrawal from opioid use following detoxification has been recognised, especially in light of the significant benefits that psychosocial support (e.g narcotics anonymous) has in maintaining abstinence in recovering opioid dependent individuals. Current drugs used to treat heroin addiction have limited success in reducing these emotional withdrawal symptoms and in preventing relapse. A study from Dr. Baileys’ laboratory showed promising effect of the drug hormone oxytocin in attenuating the negative emotional consequences of opioid withdrawal and in preventing relapse in mice. The purpose of this pilot study is to test whether nasal administration of oxytocin is effective in assisting recovering opioid (mostly heroin) dependent individuals maintain abstinence from opioid use following admission to detoxification programme; in increasing retention rates in post detoxification rehabilitation programme; in lowering their craving for opioids; in decreasing their anxiety (including social anxiety) and in improving mood, sleep quality, social cognition and quality of life. If the results prove convincing, this information will drive a larger adequately powered trial in a larger population of opioid dependent individuals.
REC name
London - London Bridge Research Ethics Committee
REC reference
14/LO/1495
Date of REC Opinion
16 Oct 2014
REC opinion
Further Information Favourable Opinion