Short versus long buprenorphine-naloxone treatment in intravenous buprenorphine withdrawal: a randomised controlled trial

Completed

Conditions: Intravenous misuse of buprenorphine
Mental and Behavioural Disorders
Opiate dependence

Registration Number: ISRCTN72781592

Lead Sponsor: Helsinki Deaconess Institute (Finland)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 120

Inclusion Criteria

1. Opiate dependence (Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition [DSM IV])
2. Current misuse of buprenorphine intravenously (mimimun 3 mg/day) (use confirmed by urinalysis)
3. Willingness to participate in withdrawal in the treatment centre and in rehabilitation afterwards
4. Aged between 18 and 50

Exclusion Criteria

1. Other than buprenorphine as the primary drug of misuse
2. Misuse of other opiates then buprenorphine during the last week (confirmed by urinalysis)
3. Opiate maintenance therapy
4. Psychotic symptoms at recruitment
5. Psychiatric or somatic disease or symptoms that may require hospitalisation at near future
6. Salient increase in alanine aminotransferase (ALAT)
7. Pregnancy
8. Allergy to lofexidine, buprenorphine or naloxone
9. Former participation to the same study
10. Concurrent participation to other intervention studies
11. Native language other than Finnish

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Completion of withdrawal<br>2. Retention in rehabilitation for one month<br>3. Abstinence at one month after withdrawal<br>4. Abstinence at six months after withdrawal

Secondary Outcome Measures

Name	Time	Method
1. The extent of withdrawal symptoms experienced, recorded every day during withdrawal<br>2. The amount of additional medication needed, recorded every day during withdrawal<br>3. Whether the patient begins naltrexone medication, patients will be offered an opportunity to begin naltrexone three days before finishing withdrawal <br>4. Patient satisfaction, measured at the last day of withdrawal, whether at the intended finishing date, or at premature termination of withdrawal. Satisfaction will be measured by a self-made questionnaire of seven questions concerning the satisfaction with the medication, the length of medication, the additional medication, the length of withdrawal, the staff, the opportunity of beginning naltrexone and the overall satisfaction with the withdrawal treatment. Answers will be recorded with a five-grade scale