NCT01473719

Brief Summary

The purpose of this study is to if a brief motivational intervention, compared to health education sessions, reduces alcohol and marijuana use and is related to fewer sexually transmitted infections (STI)in emerging adults who are engaging in alcohol and marijuana use.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
566

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jan 2012

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 15, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 17, 2011

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2012

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

September 18, 2017

Status Verified

September 1, 2017

Enrollment Period

5.6 years

First QC Date

November 15, 2011

Last Update Submit

September 15, 2017

Conditions

Alcohol UseMarijuana UseSexually Transmitted Infections

Keywords

alcohol usemarijuana useSTI

Outcome Measures

Primary Outcomes (3)

  • alcohol use

    15 months

  • marijuana use

    15 months

  • sexually transmitted infection

    15 months

Study Arms (2)

motivational intervention

ACTIVE COMPARATOR

7-session individual motivationally-based intervention

Behavioral: motivational intervention

health education

PLACEBO COMPARATOR

7-session individual session focusing on health education

Behavioral: health education

Interventions

motivational interventionBEHAVIORAL

7-session individual motivationally-based intervention

motivational intervention
health educationBEHAVIORAL

7 individual sessions focusing on health education

health education

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Be between the ages of 18 and 25
  • Binge drink (5 or more drinks in a 2-hour period for men, 4 or more for women) at least monthly
  • Use marijuana at least weekly
  • Have been heterosexually active in the past six months
  • Are not married
  • Have not been living with a sexual or romantic partner for more than 6 months
  • Be English speaking
  • Reside within 20 miles of Providence, RI and plans to stay in the geographic area for the next 15 months
  • Provide contact information for at least two verifiable locator persons

You may not qualify if:

  • Have DSM-IV diagnosis of drug abuse or dependence (other than nicotine, marijuana)
  • Have DSM-IV diagnosis of alcohol dependence

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Butler Hospital

Providence, Rhode Island, 02906, United States

Location

Related Publications (4)

  • Caviness CM, Anderson BJ, Stein MD. Impact of Nicotine and Other Stimulants on Sleep in Young Adults. J Addict Med. 2019 May/Jun;13(3):209-214. doi: 10.1097/ADM.0000000000000481.

    PMID: 30461442DERIVED

  • Caviness CM, Anderson BJ, Stein MD. Energy drinks and alcohol-related risk among young adults. Subst Abus. 2017 Oct-Dec;38(4):376-381. doi: 10.1080/08897077.2017.1343217. Epub 2017 Jun 16.

    PMID: 28622099DERIVED

  • Moitra E, Christopher PP, Anderson BJ, Stein MD. Coping-motivated marijuana use correlates with DSM-5 cannabis use disorder and psychological distress among emerging adults. Psychol Addict Behav. 2015 Sep;29(3):627-32. doi: 10.1037/adb0000083. Epub 2015 Apr 27.

    PMID: 25915689DERIVED

  • Caviness CM, Tzilos G, Anderson BJ, Stein MD. Synthetic Cannabinoids: Use and Predictors in a Community Sample of Young Adults. Subst Abus. 2015;36(3):368-73. doi: 10.1080/08897077.2014.959151. Epub 2014 Sep 15.

    PMID: 25222129DERIVED

MeSH Terms

Conditions

Alcohol DrinkingMarijuana UseSexually Transmitted Diseases

Condition Hierarchy (Ancestors)

Drinking BehaviorBehaviorSubstance-Related DisordersMental DisordersCommunicable DiseasesInfectionsGenital DiseasesUrogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Michael D Stein, MD

    Butler Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 15, 2011

First Posted

November 17, 2011

Study Start

January 1, 2012

Primary Completion

August 1, 2017

Study Completion

August 1, 2017

Last Updated

September 18, 2017

Record last verified: 2017-09

Locations

US(1)