Marijuana AbusePhase 3NCT00227864
A Brief Marijuana Intervention for Adolescent Women - 1
A Phase 3 study testing Behavior Therapy and Treatment as Usual in people with Marijuana Abuse and Sexual Risk Behaviors, run by Butler Hospital at 1 site in United States.
Trial summary
The purpose of this study is to examine the efficacy of a brief motivational intervention on marijuana use and sex-risk behavior in young women. Read more about this study
- Who is it for?
- Ages 15 to 24 years, women only
- Conditions the study is for
- Marijuana Abuse, Sexual Risk Behaviors
- What is being tested?
- Behavior Therapy and Treatment as Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 326 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2004to Dec 2009
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 24 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- current marijuana use; currently sexually active; able to complete the study procedures in English
Who cannot join
- pregnant; alcohol dependence; drug dependence
Trial locations and contacts
1 site in 1 country.
United States1 site
Rhode Island Hospital
Providence, Rhode Island, 02903
About this study
Official title: A Brief Marijuana Intervention for Adolescent Women
The purpose of this study is to examine the efficacy of a brief motivational intervention on marijuana use and sex-risk behavior in young women.
Read the detailed description
This study holds the promise of developing a brief, efficacious intervention to reduce marijuana use and related sexual risk-taking behavior among the large populaton of late adolescent women who are regular marijuana users. In the abscence of intervention, these women are at heightened risk of contracting HIV and other sexually transmitted infections. Therefore it is crucial to develop an intervention that will reduce their marijuana and subsequent sexual risk taking behavior. The intervention employed in this study represents a novel adaptation of interventions that are well-supported with similar populations. If the current intervention is found to be efficacious, it can be readily integrated into a variety of treatment settings, particularly other primary care settings. In addition, this study will contribute valuable information about the relationship between marijuana use and sexual risk taking behavior and about the mechanisms of change in marijuana use in late adolescent women.
Comparison(s): Participants will be assigned, in this 6 month longitudinal study, to an assessment-only group or an assessment plus intervention group. Those in the intervention group will receive 2 motivational intervention sessions during the first 3 months of their study participation.
- Conditions
- Marijuana Abuse, Sexual Risk Behaviors
- Being tested
- Behavior Therapy, Treatment as Usual
- Keywords
- marijuana, sexual risk
- Medical subject headings
- Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavior TherapyBehavioural
Treatment as UsualOther
| Study group | Role | What they receive |
|---|---|---|
| Treatment as Usual | Placebo comparator | Participants are administered assessments at baseline, 1, 3 and 6 months Receives: Other: Treatment as Usual |
| Intervention | Experimental | Participants complete assessments at baseline, 1, 3 and 6 months, and receive a 2-session behavioral intervention at the baseline and 1-month study appointments. Receives: Behavioral: Behavior Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Marijuna use
Measured: marijuana use at 6 months
Secondary outcomes (1)
Sex-risk behavior
Measured: sex-risk behavior at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2005 (estimated)
- Study startSep 2004
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Marijuana AbuseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 326 participants (actual)
Sponsor and investigators
- Lead sponsor
- Butler Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Michael Stein, MD, National Institute on Drug Abuse (NIDA)
- Investigators
- Michael Stein, M.D., Principal investigator, Rhode Island Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00227864
- Sponsor's protocol ID
- NIDA-18954-1
- Other IDs
- R01DA018954, R01-18954-1
- Status last verified
- Nov 2015
- First submitted
- 27 Sep 2005
- Last updated
- 11 Nov 2015
- Results posted
- No
Publications
Stein MD, Caviness CM, Anderson BJ. Alcohol use potentiates marijuana problem severity in young adult women. Womens Health Issues. 2014 Jan-Feb;24(1):e77-82. doi: 10.1016/j.whi.2013.10.005.
PubMed 24439950Caviness CM, Hagerty CE, Anderson BJ, de Dios MA, Hayaki J, Herman D, Stein MD. Self-efficacy and motivation to quit marijuana use among young women. Am J Addict. 2013 Jul-Aug;22(4):373-80. doi: 10.1111/j.1521-0391.2013.12030.x.
PubMed 23795877Stein MD, Hagerty CE, Herman DS, Phipps MG, Anderson BJ. A brief marijuana intervention for non-treatment-seeking young adult women. J Subst Abuse Treat. 2011 Mar;40(2):189-98. doi: 10.1016/j.jsat.2010.11.001. Epub 2010 Dec 24.
PubMed 21185685
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Brief Marijuana Intervention for Adolescent Women
- ClinicalTrials.gov ID
- NCT00227864
- Acronym / sponsor ID
- NIDA-18954-1
- Conditions
- Marijuana Abuse, Sexual Risk Behaviors
- Keywords
- marijuana, sexual risk
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 326 participants (actual)
- Lead sponsor
- Butler HospitalUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Sep 2004
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 28 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to examine the efficacy of a brief motivational intervention on marijuana use and sex-risk behavior in young women.
Detailed description
This study holds the promise of developing a brief, efficacious intervention to reduce marijuana use and related sexual risk-taking behavior among the large populaton of late adolescent women who are regular marijuana users. In the abscence of intervention, these women are at heightened risk of contracting HIV and other sexually transmitted infections. Therefore it is crucial to develop an intervention that will reduce their marijuana and subsequent sexual risk taking behavior. The intervention employed in this study represents a novel adaptation of interventions that are well-supported with similar populations. If the current intervention is found to be efficacious, it can be readily integrated into a variety of treatment settings, particularly other primary care settings. In addition, this study will contribute valuable information about the relationship between marijuana use and sexual risk taking behavior and about the mechanisms of change in marijuana use in late adolescent women.
Comparison(s): Participants will be assigned, in this 6 month longitudinal study, to an assessment-only group or an assessment plus intervention group. Those in the intervention group will receive 2 motivational intervention sessions during the first 3 months of their study participation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment as Usual | Placebo comparator | Other: Treatment as UsualParticipants are administered assessments at baseline, 1, 3 and 6 months |
| Intervention | Experimental | Behavioral: Behavior TherapyParticipants complete assessments at baseline, 1, 3 and 6 months, and receive a 2-session behavioral intervention at the baseline and 1-month study appointments. |
Who may qualify
- Ages
- 15 to 24 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- current marijuana use; currently sexually active; able to complete the study procedures in English
Key exclusion criteria (1 listed)
- pregnant; alcohol dependence; drug dependence
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behavior Therapy | Behavioural | Intervention |
| Treatment as Usual | Other | Treatment as Usual |
Primary outcome
Marijuna use
Time frame: marijuana use at 6 months
1 secondary outcome
Sex-risk behavior
Time frame: sex-risk behavior at 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2015.
- Derived from this study: PubMed 24439950Stein MD, Caviness CM, Anderson BJ. Alcohol use potentiates marijuana problem severity in young adult women. Womens Health Issues. 2014 Jan-Feb;24(1):e77-82. doi: 10.1016/j.whi.2013.10.005.
- Derived from this study: PubMed 23795877Caviness CM, Hagerty CE, Anderson BJ, de Dios MA, Hayaki J, Herman D, Stein MD. Self-efficacy and motivation to quit marijuana use among young women. Am J Addict. 2013 Jul-Aug;22(4):373-80. doi: 10.1111/j.1521-0391.2013.12030.x.
- Derived from this study: PubMed 21185685Stein MD, Hagerty CE, Herman DS, Phipps MG, Anderson BJ. A brief marijuana intervention for non-treatment-seeking young adult women. J Subst Abuse Treat. 2011 Mar;40(2):189-98. doi: 10.1016/j.jsat.2010.11.001. Epub 2010 Dec 24.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Stein, M.D. principal investigator
Rhode Island Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Behavior Therapy and Treatment as Usual in people with Marijuana Abuse and Sexual Risk Behaviors, run by Butler Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Marijuna use (time frame: marijuana use at 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00227864, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Nov 2015.