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Oxytocin and Cognitive Behavioral Therapy in Drug Dependence

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute on Drug Abuse (NIDA) )
ClinicalTrials.gov Identifier:
NCT00975416
First received: September 10, 2009
Last updated: October 19, 2015
Last verified: October 2015
Results First Received: March 26, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double-Blind;   Primary Purpose: Treatment
Condition: Drug Dependence
Interventions: Behavioral: Cognitive Behavioral Therapy
Drug: Intranasal Oxytocin
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations

Study was conducted at an inpatient treatment center. Screening was included in the study. Also, baseline characterization was done as a within subject study with tasks and measures before randomization to oxytocin or placebo and treatment with cognitive behavioral therapy.

Methadone and outpatient cocaine arms did not recruit participants.


Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
63 participants were screened, 30 were randomized. Subjects completed a battery of tasks and measures on oxytocin and on placebo before entering into randomized treatment phase where they were assisgned to the oxytocin or placebo arm with all subjects receiving cognitive behavioral therapy during the treatment phase.

Reporting Groups
  Description
Inpatient Cocaine Oxytocin

Intranasal oxytocin administered in the context of cognitive behavioral therapy to cocaine dependent inpatients

Oxytocin Nasal Spray: Intranasal oxytocin given in the context of cognitive behavioral therapy

Inpatient Cocaine Placebo Placebo administered in the context of cognitive behavioral therapy to cocaine dependent inpatients Placebo given in the context of cognitive behavioral therapy

Participant Flow:   Overall Study
    Inpatient Cocaine Oxytocin     Inpatient Cocaine Placebo  
STARTED     14     16  
COMPLETED     11     11  
NOT COMPLETED     3     5  
early discharge from tx                 3                 5  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Inpatient Cocaine Oxytocin

Intranasal oxytocin administered in the context of cognitive behavioral therapy to cocaine dependent inpatients

Oxytocin Nasal Spray: Intranasal oxytocin given in the context of cognitive behavioral therapy

Inpatient Cocaine Placebo

Intranasal placebo administered in the context of cognitive behavioral therapy to cocaine dependent inpatients

Intranasal Placebo given in the context of cognitive behavioral therapy

Total Total of all reporting groups

Baseline Measures
    Inpatient Cocaine Oxytocin     Inpatient Cocaine Placebo     Total  
Number of Participants  
[units: participants]
  14     16     30  
Age  
[units: years]
Mean (Standard Deviation)
  41.1  (10.2)     40.8  (10.0)     40.9  (9.9)  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     14     16     30  
>=65 years     0     0     0  
Gender  
[units: participants]
     
Female     0     1     1  
Male     14     15     29  
Region of Enrollment  
[units: participants]
     
United States     14     16     30  



  Outcome Measures

1.  Primary:   Therapeutic Alliance   [ Time Frame: Post 12 weeks treatment with cognitive behavioral therapy ]

2.  Other Pre-specified:   Drug Craving   [ Time Frame: Post-treatment ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data

1 participant committed suicide outside of that occurred outside of adverse event time frame.

There were 12 occurrences of computer malfunction during the study. This did not effect data collection for primary outcome measures.



  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Mary R. Lee, M.D.
Organization: National Institute on Drug Abuse
phone: 301-825-0545
e-mail: leemary@mail.nih.gov


Publications:

Responsible Party: National Institutes of Health Clinical Center (CC) ( National Institute on Drug Abuse (NIDA) )
ClinicalTrials.gov Identifier: NCT00975416     History of Changes
Other Study ID Numbers: 999908432
08-DA-N432
Study First Received: September 10, 2009
Results First Received: March 26, 2014
Last Updated: October 19, 2015
Health Authority: United States: Federal Government