Phase 2
Completed N=12
Cognitive Behavioral Therapy and the Nicotine Transdermal Patch for Cannabis Dependence and Nicotine Dependence
Cannabis Dependence · Nicotine Dependence
Source: ClinicalTrials.gov NCT01292642 ↗
Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Aug 2013
Primary outcomePrimary: Cigarette Use — 12.6; 2.1 cigarettes/day
Summary
The investigators are conducting a Stage 1 pilot feasibility study at McLean Hospital to develop and refine a Cognitive Behavioral Therapy (CBT) intervention. The investigators aim to develop a feasible 10-week integrated CBT intervention for the treatment of concurrent marijuana dependence and nicotine dependence. The investigators hypothesize that the CBT intervention, in conjunction with Nicotine Replacement Therapy (NRT) in the form of a transdermal nicotine patch, will reduce the use of marijuana and nicotine.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cigarette Use |
12.6; 2.1 | — |
| PRIMARY Cannabis Use |
10.0; 8.0 | — |
| SECONDARY Client Satisfaction Questionnaire (CSQ-8) at 10 Weeks |
30.6 | — |
Eligibility Criteria
Inclusion Criteria
- Age range 18-65 years
- current DSM-IV cannabis dependence
- current DSM-IV nicotine dependence
- express a desire to quit cannabis and nicotine use within the next 30 days
- daily use of ≥ 10 tobacco cigarettes
- for women of childbearing age, a negative pregnancy test at screening with agreement to use adequate contraception to prevent pregnancy and additional pregnancy tests at weeks 4 and 8
- Expired breath carbon monoxide (CO) determination is greater than or equal to 7 ppm over ambient values
Exclusion Criteria
- Current diagnosis of other drug or alcohol dependence (other than cannabis or nicotine)
- recent (within 3 months) significant cardiac disease
- current serious psychiatric illness or history of psychosis, schizophrenia, bipolar type I disorder or significant current suicidal or homicidal thoughts
- current use of bupropion
- current NRT or other smoking cessation treatment
- current CBT or other behavioral treatments for cessation of marijuana or tobacco smoking
- current smokeless tobacco use
- inability to read or write in English
Data sourced from ClinicalTrials.gov (NCT01292642). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.