Alcoholism Clinical Trial
Official title:
Naltrexone for Heavy Drinking in Young Adults
Verified date | August 2018 |
Source | Yale University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
In this study, 140 heavy drinking young adults (aged 18-25) will be provided with brief counseling and either naltrexone, a medication that is FDA-approved for the treatment of alcohol dependence, or placebo over the course of 8 weeks. A novel strategy will be used for administering low-dose naltrexone, in which daily dosing will be combined with targeted dosing in anticipation of high-risk situations. The main hypotheses are that daily + targeted naltrexone will result in greater reductions in frequency of heavy and any drinking compared with daily + targeted placebo.
Status | Completed |
Enrollment | 140 |
Est. completion date | December 2012 |
Est. primary completion date | December 2012 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 25 Years |
Eligibility |
Inclusion Criteria: Each subject must: 1. Be between the ages of 18 and 25; 2. Report heavy drinking 4 or more times in the past 4 weeks. Heavy drinking is defined as 4 or more drinks for women and 5 or more drinks for men on an occasion; 3. Be able to read English and show no evidence of significant cognitive impairment. 4. That women of child-bearing potential (i.e., who has not had a hysterectomy, bilateral oophorectomy, or tubal ligation), be nonlactating, practicing a reliable method of birth control, and have a negative urine pregnancy test prior to initiation of treatment. Exclusion Criteria: No subject may: 1. Exhibit current, clinically significant physical disease or abnormality on the basis of medical history, physical examination, or routine laboratory evaluation, including AST or ALT levels greater than 3 times normal or bilirubin levels greater than 110% of normal. Individuals with common medical conditions (e.g., asthma, diabetes mellitus, thyroid disease) that are adequately controlled and who have a relationship with a primary-care practitioner will not be excluded; 2. Exhibit serious psychiatric illness (i.e., schizophrenia, bipolar disorder, severe major depression, panic disorder, borderline personality disorder, organic mood or mental disorders, or substantial suicide or violence risk) by history or psychological examination; 3. Have a current diagnosis of DSM-IV drug dependence other than nicotine, or a lifetime history of DSM-IV opiate dependence; 4. Have a current DSM-IV diagnosis of alcohol dependence that is clinically severe defined by a) a history of seizures, delirium, or hallucinations during alcohol withdrawal, b) a Clinical Institute Withdrawal Assessment scale (Sullivan et al., 1989) score of > 8, c) report drinking to avoid withdrawal symptoms, or d) have had prior treatment of withdrawal. 5. Have used opioids or concomitant therapy with any psychotropic drug in the past month, except that subjects who are on a stable dose of a Selective Serotonin Reuptake Inhibitor for at least two months for the indications of Major Depressive Disorder, Premenstrual Syndrome (PMS), or Premenstrual Dysphoric Disorder (PMDD) will not be excluded; SSRIs are allowed due to their safety profile relative to other classes of antidepressants. 6. Have a history of hypersensitivity to naltrexone; 7. Be considered by the investigators to be an unsuitable candidate for receipt of an investigational drug. 8. The investigators may exclude participants who complete daily questionnaires on less than half of the days between intake and treatment. |
Country | Name | City | State |
---|---|---|---|
United States | Connecticut Mental Health Center - Substance Abuse Treatment Unit | New Haven | Connecticut |
Lead Sponsor | Collaborator |
---|---|
Yale University | National Institute on Alcohol Abuse and Alcoholism (NIAAA) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Frequency of Heavy Episodic Drinking | Self-reported drinking was primarily obtained through diary data, with the Timeline Follow-Back Interview (TLFB) used to replace missing data at baseline and at each biweekly visit over the 8-weeks.The eight weeks follow-up measure is summarized across all biweekly visits. Frequency of heavy episodic drinking is measured as 5 or more drinks in a day for males, and 4 or more drinks in a day for females. A standard drink was equivalent to 0.6 gm of absolute alcohol (e.g., 12-oz beer, 5-oz wine, or 1.5-oz, 80-proof liquor). Baseline measures captured the prior 4 weeks. | Baseline | |
Primary | Frequency of Heavy Episodic Drinking | Self-reported drinking was primarily obtained through diary data, with the Timeline Follow-Back Interview (TLFB) used to replace missing data at baseline and at each biweekly visit over the 8-weeks.The eight weeks follow-up measure is summarized across all biweekly visits. Frequency of heavy episodic drinking is measured as 5 or more drinks in a day for males, and 4 or more drinks in a day for females over an eight week period. A standard drink was equivalent to 0.6 gm of absolute alcohol (e.g., 12-oz beer, 5-oz wine, or 1.5-oz, 80-proof liquor). |
eight weeks | |
Primary | Percent Days Abstinent From Drinking | Self-reported drinking was primarily obtained through diary data, with the Timeline Follow-Back Interview (TLFB) used to replace missing data at baseline and at each biweekly visit over the 8-weeks.The eight weeks follow-up measure is summarized across all biweekly visits. Baseline measures captured the prior 4 weeks. | Baseline | |
Primary | Percent Days Abstinent From Drinking | Self-reported drinking was primarily obtained through diary data, with the Timeline Follow-Back Interview (TLFB) used to replace missing data at baseline and at each biweekly visit over the 8-weeks.The eight weeks follow-up measure is summarized across all biweekly visits. | 8 Weeks | |
Secondary | Number of Drinks Per Drinking Day | Self-reported drinking was primarily obtained through diary data, with the Timeline Follow-Back Interview (TLFB) used to replace missing data at baseline and at each biweekly visit over the 8-weeks.The eight weeks follow-up measure is summarized across all biweekly visits. Baseline measures captured the prior 4 weeks. | Baseline | |
Secondary | Number of Drinks Per Drinking Day | Self-reported drinking was primarily obtained through diary data, with the Timeline Follow-Back Interview (TLFB) used to replace missing data at baseline and at each biweekly visit over the 8-weeks.The eight weeks follow-up measure is summarized across all biweekly visits. | 8 Weeks | |
Secondary | Percentage of Drinking to an Estimated Blood Alcohol Concentration (BAC) of .08 or Higher | Self-reported drinking was primarily obtained through diary data, with the Timeline Follow-Back Interview (TLFB) used to replace missing data at baseline and at each biweekly visit over the 8-weeks.The eight weeks follow-up measure is summarized across all biweekly visits. BAL (Blood Alcohol Level) was estimated using data from the daily diaries based on the number of drinks consumed, the duration of drinking, and total body water (based on gender, age, height and weight) using Curtin's formula. |
8 weeks |
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 | |
Terminated |
NCT01408641 -
Topiramate for Alcohol Use in Posttraumatic Stress Disorder
|
N/A | |
Completed |
NCT01553136 -
Varenicline Treatment of Alcohol Dependence in Smokers
|
Phase 2 | |
Completed |
NCT01389297 -
Overcoming Addictions: A Randomized Clinical Trial of a Web Application Based on SMART Recovery
|
N/A | |
Completed |
NCT01113164 -
Matching Genotypes and Serotonergic Medications for Alcoholism
|
Phase 1 | |
Completed |
NCT00768508 -
Combined Pharmacotherapies for Alcoholism
|
Phase 3 | |
Completed |
NCT01760785 -
Valproate for Mood Swings and Alcohol Use Following Head Injury
|
N/A | |
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 |
NCT00223639 -
New Medications to Treat Alcohol Dependence
|
Phase 2 | |
Completed |
NCT00167687 -
Prazosin Alcohol Dependence IVR Study
|
Phase 4 | |
Completed |
NCT00583440 -
12-step Facilitation for the Dually Diagnosed
|
Phase 1/Phase 2 |