Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00688584
Other study ID # 301/2006
Secondary ID
Status Completed
Phase N/A
First received May 30, 2008
Last updated April 8, 2013
Start date December 2008
Est. completion date December 2010

Study information

Verified date April 2013
Source Centre for Addiction and Mental Health
Contact n/a
Is FDA regulated No
Health authority Canada: Health Canada
Study type Interventional

Clinical Trial Summary

The major objective of this proposal is to conduct a randomized controlled trial of an ultra-brief, personalized feedback intervention (a pamphlet) for problem drinkers. Subjects will be recruited via a telephone survey which will collect baseline data. The households of half of the subjects will receive the pamphlet as unaddressed ad mail shortly thereafter. Follow-up interviews will be conducted, by telephone, three and six months after the mailing of the pamphlets.

Hypothesis 1: Respondents from households who receive the pamphlet will display significantly improved drinking outcomes at the three-month and six-month follow-ups as compared to respondents from households in the no intervention control condition.

Hypothesis 2: More calls will be received on a help-line listed on the pamphlet (and advertised elsewhere) from residents of households who receive the pamphlet as compared to residents from households who do not receive the pamphlet.

Hypotheses 3 - 6 deal with mediator and moderator hypotheses, exploring the role of perceived risk, perceived drinking norms, and drinking for social reasons.


Description:

How do we help those problem drinkers who will never seek treatment? This is a challenging issue because of the large number of problem drinkers and the limited amount of resources available. Public health initiatives employing educational materials have met with little or no success. However, clinical research has developed effective brief interventions to help problem drinkers. This project will merge these two worlds, modifying a clinically developed intervention and producing it in an ultra-brief format that is suitable for use as a public health intervention. The major objective of this proposal is to conduct a randomized controlled trial of an ultra-brief, personalized feedback intervention for problem drinkers. The advantages of the personalized feedback pamphlet are that it is low cost and can be widely distributed to the population of problem drinkers who never seek treatment. Because the materials are based on some of the best of research-based interventions, such an ultra-brief normative feedback pamphlet has the potential of helping problem drinkers. An effective intervention of this type would yield significant public health benefit. 1830 problem drinkers will be recruited on a baseline population telephone survey and randomized to one of three conditions - personalized feedback pamphlet condition, control pamphlet condition (to test if it is the specific content of the pamphlet that leads to the change or just the receipt of any pamphlet) and a no intervention control condition (sent intervention pamphlet after the six-month follow-up). In the week after the baseline survey, all households in the postal code areas that contain respondents in the two pamphlet conditions will be sent their respective pamphlets. Changes in drinking will be assessed on post intervention three-month and six-month follow-ups. Drinking outcomes will be compared between experimental conditions. The primary hypothesis is that respondents from households who receive the personalized feedback pamphlet intervention will display significantly improved drinking outcomes at three and six-month follow-ups as compared to respondents from households in the no intervention control condition. Secondary hypotheses will test the impact of the intervention on help seeking, and explore the mediating or moderating role of perceived drinking norms, perceived risk and the problem drinker's social reasons for drinking.


Recruitment information / eligibility

Status Completed
Enrollment 1767
Est. completion date December 2010
Est. primary completion date December 2010
Accepts healthy volunteers No
Gender Both
Age group 19 Years and older
Eligibility Inclusion Criteria:

- Age 19 years or more

- Audit score of 8 or more (the AUDIT is a validated screener, developed by WHO, to identify problem drinkers in the community and health-care settings)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
Pamphlet-based personalized alcohol feedback (PAF)
participants in this condition will be mailed their respective pamphlets
control pamphlet condition
The goal is to test if it is the specific content of the pamphlet that leads to the change or just the receipt of any pamphlet.

Locations

Country Name City State
Canada University of Alberta Edmonton Alberta
Canada Centre for Addiction and Mental Health Toronto Ontario
United States University of Washington Seattle Washington
United States Stanford University School of Medicine Stanford California

Sponsors (2)

Lead Sponsor Collaborator
Centre for Addiction and Mental Health National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary frequency of alcohol consumption measured at 3 and 6 months into the study No
Primary alcoholic drinks per occasion measured at 3 and 6 months into the study No
See also
  Status Clinical Trial Phase
Recruiting NCT05054738 - CRP and S&A for Inpatient Veterans N/A
Completed NCT02233738 - Group Motivational Interviewing (GMI) For Homeless Veterans In VA Services N/A
Completed NCT05877807 - Effect of Baclofen to Prevent Post-Traumatic Stress Disorder
Completed NCT00000437 - Tobacco Dependence in Alcoholism Treatment (Nicotine Patch/Naltrexone) Phase 4
Completed NCT00536146 - The Stress-Hormone System in Alcohol-Dependent Subjects N/A
Terminated NCT00890149 - Ondansetron for the Treatment of Heavy Drinking Among Emerging Adults Phase 2
Completed NCT02939352 - The Effects of Theta Burst Stimulation on the Brain Response to Drug and Alcohol Cues Early Phase 1
Completed NCT02179749 - Mifepristone Treatment of Alcohol Use Disorder Phase 2
Completed NCT01553136 - Varenicline Treatment of Alcohol Dependence in Smokers Phase 2
Terminated NCT01408641 - Topiramate for Alcohol Use in Posttraumatic Stress Disorder N/A
Completed NCT01389297 - Overcoming Addictions: A Randomized Clinical Trial of a Web Application Based on SMART Recovery N/A
Completed NCT00768508 - Combined Pharmacotherapies for Alcoholism Phase 3
Completed NCT01760785 - Valproate for Mood Swings and Alcohol Use Following Head Injury N/A
Completed NCT01113164 - Matching Genotypes and Serotonergic Medications for Alcoholism Phase 1
Completed NCT00127231 - Brief Therapy Intervention for Heavy/Hazardous Drinking in HIV-Positive Women N/A
Terminated NCT02842528 - Cognitive Vulnerability Factors in Alcohol-dependence N/A
Completed NCT00367575 - An Internet-based Intervention for Problem Drinking N/A
Completed NCT00583440 - 12-step Facilitation for the Dually Diagnosed Phase 1/Phase 2
Completed NCT00167687 - Prazosin Alcohol Dependence IVR Study Phase 4
Completed NCT00223639 - New Medications to Treat Alcohol Dependence Phase 2